Regulatory Compliance Associates® will be exhibiting at INTERPHEX in New York City from April 1st–3rd 2025 with Sterigenics and Nelson Labs. Stop by booth #1753 to meet experts from each team to learn how we can provide you with a complete solution for any of your projects. Together we understand your business and are prepared to discuss solutions to your regulatory, quality, compliance, sterilization, and lab testing needs to help ensure the safety of your product and process.
About Interphex®
For 40+ years, INTERPHEX has been the premier pharmaceutical, biotechnology, and medical device development and manufacturing event where you can “Experience Science through Commercialization”.
Based in New York, INTERPHEX brings over 10,500 global industry professionals and 620+ suppliers together to “Learn It, Experience It, Procure It” through a unique combination of our no-cost technical conference, exhibits, demonstrations, partnering opportunities, and networking events to leverage quality, efficiency, and cost-effectiveness in today’s ever-changing global market.
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
Regulatory policies in the MedTech and pharmaceutical industries often shift with new administrations. With the current administration proposing sweeping changes, including deregulation, updates to FDA structure and processes, and tariff implementation this blog explores key regulatory changes, their implications, and how businesses can adapt.
One of the administration’s primary goals is reducing regulatory burdens on businesses. Previous efforts included requiring the removal of two existing regulations for every new one introduced, and the administration will implement a policy mandating the elimination of ten regulations for every new one enacted. While deregulation could simplify compliance, it may also create significant uncertainties, particularly regarding safety standards and quality assurance. MedTech and pharmaceutical companies must actively track regulatory developments, assess potential risks, and implement strategic measures to ensure ongoing compliance to position themselves for long-term success in an evolving regulatory landscape.
FDA Workforce Reductions & Product Approval Timelines
FDA review timelines for drugs fall under the Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Amendments (GDUFA) which regulate review periods for New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) are set through 2027. Similarly, medical device approval timelines fall under the Medical Device User Fee Amendments (MDUFA), which regulate review periods for premarket approvals (PMA) and 510(k) clearances are also set through 2027. While these timelines are unlikely to change, workforce reductions at the FDA may lead to delays, across both drug and medical device reviews. The administration’s focus on automation and AI-driven processes may help counterbalance delays, but adoption of these technologies remains in its early stages. Companies can prepare for possible slowdowns by ensuring their submissions are complete, well-documented, and structured for easy review to avoid costly submission delays.
Changes in FDA Inspections and Compliance Expectations
Budget constraints and workforce cuts may lead to longer wait times for FDA re-inspections. In response, the agency is increasing its reliance on remote audits and digital compliance measures. As the FDA is expected to place greater emphasis on data integrity, AI-assisted compliance monitoring, and risk-based assessments to prioritize critical inspections, companies can strengthen their electronic record-keeping and cybersecurity frameworks to prepare for successful remote, as well as onsite, inspections.
The Impact of Tariffs and Trade Policies on Supply Chains
The administration has signaled tariff increases on imported raw materials and medical components, which could significantly impact MedTech and pharma supply chains. Many companies source materials from countries where production costs are lower, but new tariffs may force them to reconsider domestic sourcing or alternative suppliers. Companies can qualify alternative suppliers and appropriately assess the impact of any resulting device or drug product changes with additional testing, documentation, and submission to regulatory bodies, where appropriate.
Challenges for Industry Collaboration
A recent policy change has limited the FDA’s participation in industry conferences, working groups, and regulatory collaboration efforts. This has raised concerns about delays in regulatory standardization, test method approvals, and knowledge-sharing initiatives. Companies can take proactive steps to engage with industry organizations, participate in independent regulatory forums, and collaborate with peers to fill the information gap left by the FDA’s reduced engagement. Partnering with regulatory consultants and leveraging external expertise can also ensure continued compliance and strategic industry positioning.
Key Takeaways: How Companies Can Prepare
Enhance Regulatory Compliance: Strengthen quality management systems (QMS) and prioritize data integrity to meet evolving regulatory expectations.
Prepare for Remote Inspections: Adopt robust digital record-keeping practices and cybersecurity measures to accommodate the FDA’s shift toward virtual audits.
Diversify Supply Chains: Evaluate sourcing strategies to mitigate risks associated with potential tariff increases and supply chain disruptions.
Stay Engaged with Industry Networks & Leverage Consultants Where Needed: Participate in professional organizations and working groups to stay informed about regulatory updates and best practices. Consider engaging third-party consulting services with agencies that maintain close relationships with regulatory bodies to bridge internal gaps.
Conclusion
The evolving regulatory landscape under the new administration presents both opportunities and challenges for the MedTech and pharmaceutical industries. While deregulation efforts may ease compliance burdens, companies must remain vigilant regarding workforce reductions, evolving inspection protocols, and supply chain disruptions. To successfully navigate these changes, businesses should proactively enhance compliance measures, integrate technological advancements, and foster industry collaboration.
How We Can Help
Adapting to these regulatory shifts requires expertise and strategic planning. Regulatory Compliance Associates (RCA) and Nelson Labs offer industry-leading guidance in regulatory affairs, quality assurance, compliance, and laboratory testing. Our experienced advisors help organizations interpret evolving requirements, implement best practices, and successfully resolve complex regulatory challenges to bring safe and effective products to market.
To begin the Regulatory Compliance Associates and Nelson Labs scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
For companies operating in FDA-regulated industries—such as pharmaceuticals, medical devices, food manufacturing, and biotechnology—FDA inspections are an inevitable and crucial part of maintaining compliance. Understanding the inspection process and preparing adequately can make a significant difference in ensuring a smooth experience and maintaining compliance with FDA regulations.
Why Does the FDA Conduct Inspections?
The FDA (Food and Drug Administration) conducts inspections to ensure that companies manufacture high quality products and comply with federal regulations regarding the safety, efficacy, quality and labeling of their products. Inspections serve to verify that manufacturing facilities follow Good Manufacturing Practices (GMPs), adhere to safety guidelines, and produce products that meet established standards. The legal authority for inspections is outlined in the Federal Food, Drug, and Cosmetic Act (FD&C Act) 21 U.S.C. §374.
Types of FDA Inspections
FDA inspections can fall into several categories, including:
Pre-Approval Inspections (PAI): Conducted before the FDA grants approval for a new product. These inspections verify the accuracy of the information submitted in regulatory applications (21 CFR Part 314.125 for drugs, 21 CFR Part 814.42 for medical devices).
Routine Surveillance Inspections: Periodic inspections to ensure ongoing compliance with regulations. These can be announced or unannounced (21 CFR Part 820 for medical devices, 21 CFR Part 211 for pharmaceuticals).
For-Cause Inspections: Triggered by a specific concern, such as a complaint, adverse event, or suspected regulatory violation (21 CFR Part 7.3(g) outlines recall classifications based on these inspections).
Compliance Follow-Up Inspections: Conducted to verify corrective actions taken in response to previous inspection findings.
Sampling During Pharma Inspections
To help ensure that high-quality drugs are sold in the U.S., FDA maintains a comprehensive quality surveillance program. A critical function of this program is testing selected drugs in FDA laboratories. This includes testing active pharmaceutical ingredients (APIs). FDA laboratories generally test drugs to standards set by the U.S. Pharmacopeia (USP), an organization that publishes quality monographs for medicines including attributes such as:
Identity: is it the right drug as indicated on the label?
Assay: how much drug is there and is it consistent with the labeled amount?
Impurities: are impurities within established specifications?
Dissolution: does the active ingredient dissolve out of the dosage unit so that the drug is available for the body to absorb?
FDA quality surveillance program includes multiple tools that complement sampling and testing. These tools include sampling assignment as a result of inspections, evaluation of post-market quality reports, signal detection, and data analysis.
What Happens During an FDA Inspection?
While each inspection may vary slightly depending on the industry and facility type, most follow a structured process:
Notice of Inspection: The FDA may or may not provide advance notice of an inspection. When notified, companies should quickly organize relevant personnel and documentation (FDA Form 482 – Notice of Inspection).
Opening Meeting: The FDA investigator(s) will present their credentials and explain the purpose and scope of the inspection.
Facility Walkthrough: Inspectors tour the facility, observe operations, and assess compliance with regulatory requirements.
Document and Record Review: The FDA will request to review various documents, such as standard operating procedures (SOPs), batch records, testing, employee training records, deviation reports, verify data integrity, ALCOA and (21 CFR Part 11 for electronic records and signatures).
Interviews: Inspectors may interview employees at various levels to gauge their understanding of compliance requirements and daily operations.
Observations and Notations: Any potential violations or concerns are noted, typically recorded on FDA Form 483 and issued at the close of an inspection.
Closing Meeting: The inspector provides preliminary feedback and discusses any observations that may require corrective actions.
How to Prepare for an FDA Inspection
Maintain a State of Readiness: Always operate as if an inspection could occur at any time.
Train Employees: Ensure that staff members understand regulatory requirements and are prepared to answer questions confidently and accurately.
Conduct Internal Audits: Regular self-inspections can help identify and address potential compliance gaps before an FDA inspection.
Organize Documentation: Maintain well-organized, readily accessible records to streamline the document review process.
Establish an Inspection Plan: Have a clear strategy in place, including designated personnel to guide inspectors, manage documentation requests, and address findings promptly.
Post-Inspection Actions
After an FDA inspection, the company may receive an FDA Form 483 if compliance issues were noted. Addressing these findings promptly through corrective and preventive actions (CAPAs) is crucial to demonstrating commitment to compliance. In some cases, the FDA may issue a Warning Letter (21 CFR Part 7.3) if significant violations are found, which requires a more formal response and resolution.
Conclusion
An FDA inspection is a critical event that can impact a company’s ability to operate and bring products to market. Proper preparation, adherence to regulatory standards, and a proactive compliance culture can help companies navigate inspections successfully. By staying informed and ready, businesses can not only pass inspections but also strengthen their overall compliance programs and ensure public safety.
Are you prepared for an inspection at your facility? Regulatory Compliance Associates® (RCA) can help your team prepare for inspections, manage inspections or help remediate any adverse findings once the inspection is complete. From developing a training program that suits your professional needs, company goals, and preferred learning style. To working with your leadership to create a response strategy, we have you covered.
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
The FDA is cracking down on labeling for drug products that will require companies to reevaluate and make changes to new and existing products if they wish to stay in compliance. To ensure companies can continue production without slowdowns, it is important to understand what changes are being implemented and how they will affect your products.
Greater Transparency in NDA and ANDA Labeling
In April 2024, the FDA released a draft guidance aimed at improving transparency in drug labeling, particularly for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs), which cover generic drugs. Generic drug labeling must contain information to show that the proposed labeling is the same as that for the Reference Listed Drug (RLD), with certain permissible differences. Under 21 CFR 314.50, an NDA must contain a list of all components used in the manufacture of the drug product. However, historically, there have been several instances whereby the NDA did not disclose all of its ingredients in the labeling, leading to complications in the regulatory approval process for generic versions. This lack of transparency created delays and regulatory hurdles for ANDAs that relied on accurate ingredient information from their RLD.
Moving forward, the FDA is advocating for clearer and more comprehensive ingredient disclosures on NDA and ANDA labels. For example, labeling for non-oral drug products may need to contain the names of all inactive ingredients with limited exceptions. This shift is intended to eliminate unnecessary review delays and improve the efficiency of ANDA approvals. While the exact compliance strategies remain unclear, the draft guidance from April 2024 is expected to shape regulatory expectations well into 2025 and beyond once the guidance becomes finalized.
This change marks a significant step toward improving the drug approval process. Greater transparency in ingredient listings will not only help generic drug manufacturers but also ensure that healthcare providers and consumers have access to complete information about their medications. The push for increased clarity aligns with broader FDA efforts to enhance drug safety and efficacy.
New Labeling Rules for OTC Drugs
Another critical update in drug labeling comes with the final rule for non-prescription (over-the-counter, or OTC) drugs under the Additional Condition of Nonprescription Use (ACNU) framework. Published in December 2024, this rule introduces new labeling requirements for certain OTC products to enhance consumer safety and regulatory oversight.
Under the ACNU framework, some OTC drugs will require additional steps before consumers can access them. These measures may include visiting the manufacturer’s website or completing a brief manufacture’s to determine whether the product is suitable for individual use. This regulatory approach seeks to strike a balance between expanding consumer access to safe and effective nonprescription medications while ensuring that people use them appropriately.
The implementation of this rule could significantly impact both consumers and pharmaceutical companies. On one hand, it enhances safety measures by ensuring that individuals receive proper guidance before using certain OTC drugs. On the other hand, companies will need to update their packaging, labeling and digital platforms to comply with the new requirements. Consumers may also need to adapt to these changes by engaging with manufacturers’ resources before purchasing certain OTC products. The final rule is intended to increase options for consumer access to appropriate, safe, and effective drug products, which could improve public health.
What to Expect
These labeling and transparency initiatives will likely play a major role in shaping the pharmaceutical landscape in the future. The FDA’s push for improved ingredient disclosure in NDAs and ANDAs is expected to streamline generic drug approvals and foster greater trust in drug labeling. Meanwhile, the ACNU framework will redefine how consumers interact with select OTC medications, prioritizing informed decision-making and responsible use.
Stakeholders, including drug manufacturers, healthcare providers, and consumers, should stay informed about these evolving regulations to ensure compliance and safe medication practices. As the FDA continues refining its policies, further clarifications and potential updates may emerge, reinforcing the agency’s commitment to transparency and consumer safety in the pharmaceutical industry.
Preparing for These Changes
For companies looking to stay ahead of these regulatory updates and maintain seamless approvals and production, it is essential to assess current processes and identify gaps in compliance with the new FDA guidelines. Engaging with third-party auditors with relevant expertise can help pinpoint deficiencies and develop a robust implementation strategy, ensuring compliance from the outset.
At RCA, we leverage our extensive network of industry experts, including former FDA consultants and leading auditors, to provide comprehensive support. Whether identifying and addressing compliance gaps or designing entirely new processes for emerging products, our team ensures a seamless transition to meet evolving regulatory expectations. Let us help you identify any gaps and help you form a clear strategy that will keep your drug labels in compliance today.
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
In this soundbite from RCA Radio, Erika Porcelli, CEO of Regulatory Compliance Associates® (RCA), provides examples of how different size companies leverage the stage of business they’re in to accelerate development with outsourced staff.
Start ups vs Large Companies
Using Staff augmentation to bring in SMEs gives companies the ability to scale up and scale down quickly without taking away people from other projects.
Start-ups are typically not ready to bring on a full-time employee. In cases like these, we can bring in a subject matter expert (SME) that can help work through any regulatory, compliance, or quality problem and assist on an as-needed base.
Larger companies typically need help when they are performing a project such as adding a new manufacturing line into a facility. They don’t do this all of the time and only need the extra resources for this particular project. In cases like these, we will put together a team with the right skillsets that can complete the particular project. Once completed, RCA perform a hand-off with the client, and our team steps away from the project.
All companies experience staffing support issues whether they are transient and short-lived, chronic and unplanned, or intrinsic to your business model. RCA has consultants that develop a solution to your specific needs; we can help “right-size” your team when and where you need it most.
Outsourcing has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the life cycle of the organization. These companies turn to outsourcing to manage operations and tactical skills, and also help adopt best practices.
Successful execution comes through project monitoring, issue resolution, and risk management of the process through clear leadership. RCA’s team of experienced project management professionals organize and manage resources to ensure that projects are completed successfully, on time, and within budget.
RCA Outsourcing Services
Project Management
To be successful in the field of manufacturing, you must have a proper project management plan in place. Not only do project management procedures keep your projects on time and on schedule, but they also ensure your devices’ compliance with stringent national and international regulations. RCA can help you develop an effective plan, and we can even lead these tasks so that you can run more projects at one time more efficiently.
Our outsourced staff capabilities for project management capabilities include:
On-site Project Leadership or Project Management Support
Design and Implementation of a Project Management Office
Development and Implementation of Compliant Methods
Risk Management
Issues Resolution and Decision Tracking
Change Management
Performance Measurement and Tracking
Tool Selection for Program Portfolio and Resource Management
Staff Augmentation
Many companies need the assistance of a professional with specific skills and expertise when completing a project but might not have the need or resources to hire this expert as a full-time employee. Instead, you can add experienced professionals to your staff for a short- or long-term project through our medical device staffing support capabilities. RCA’s outsourcing solutions can help you manage even your most complex projects with experts trained in areas such as:
Quality Assurance
Regulatory Affairs
Validation
Operations
Product Development
Consulting Support
Maybe your company is struggling to complete projects on time, or perhaps you often face challenges associated with product compliance. Whatever your situation, our consultants will work with you to ensure your business’ success with consulting support services. By getting to know more about your business and goals, we’ll tailor our approach to best meet your particular needs.
Advantages of Outsourcing
When you hit a snag in your project’s development, you need to design and develop the best solution to create a timely, quality finished product. RCA’s quality assurance and regulatory affairs consultants can help you define the specific problem, generate ideas for a potential solution, and implement that solution for the utmost success in your project’s completion.
Our goal is to help you get your projects to completion on time and on budget — all while outsourced staff keeps superior quality at the forefront of your every task. And with a team of more than 500 pharmaceutical consultants and industry experts with an average of 25 years of experience in the life science industries, we have the extensive resources and expertise needed to meet this goal.
Strategic Outsourcing
Medical device manufacturers face the challenging task of creating top-quality products quickly with minimal personnel and growing compliance regulations to adhere to. With these increasing challenges, it’s no wonder so many local startups and Fortune 100 companies alike choose RCA for outsourced staff and strategic outsourcing services.
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
In an interview withPharmaceutical Technology®, Susan Schniepp, distinguished fellow, Regulatory Compliance Associates®, and co-chair of board of directors, Parenteral Drug Association, expands on the importance of maintaining a robust quality management system (QMS) in bio/pharmaceutical manufacturing.
For advanced therapy medicinal products (ATMPs) in particular, Schniepp emphasizes how fast-moving this sector is. “The regulations don’t keep up with the ATMPs. That technology, and their way of thinking, is turning over quicker than the regulatory standards,” she says.
“The changes in the regulations that are going to come are going to be around quality culture and maintaining a robust quality management system,” she adds. Ensuring documentation and keeping equipment calibrated are important practices to apply to these new fast-moving ATMPs, she states. Schniepp does not necessarily expect to see many changes in the regulations around ATMP development and manufacturing but thinks that there will likely be more guidance documents issued in the future, with one of FDA’s focuses being its quality management maturity model.
“There are some regulations out there that call out quality culture. In particular, the World Health Organization has one on data integrity. It has a definition and standard[s] on what quality culture is,” Schniepp says. She points out that a new aspect of her presentation at INTERPHEX this year is its interactive component, in which she sets up a scenario involving an internal audit where an incident occurs. She gives the audience three potential responses to discuss, but rather than simply asking them which response do they pick or which response is correct, she instead asks what does the chosen response say about that person or that company’s QMS and the maturity of that system?
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
The FDA (Food and Drug Administration) conducts inspections to ensure that companies manufacture high quality products and comply with federal regulations regarding the safety, efficacy, quality and labeling of their products. Inspections serve to verify that manufacturing facilities follow Good Manufacturing Practices (GMPs), adhere to safety guidelines, and produce products that meet established standards. The legal authority for inspections is outlined in the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
To be successful in the field of manufacturing, you must have a proper project management plan in place. Not only do project management procedures keep your projects on time and on schedule, but they also ensure your devices’ compliance with stringent national and international regulations. RCA can help you develop an effective plan, and we can even lead these tasks so that you can run more projects at one time more efficiently.