Shorten FDA Approval Times by Minimizing the Impact of Product Changes

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Along with FDA approval for a drug or device comes a myriad of post-approval commitments the company must keep.

Most notable among these commitments is to inform the FDA of post-approval changes. Set into action, this means that all post-approval changes that might impact the CMC section or product label must be evaluated to determine what the change means in terms of regulatory action the company may need to take.

The FDA must be informed of every change. The question is whether you will inform them by filing a Prior Approval Supplement (PAS), changes being effective (CBE30 or CBE0) or by including the updated information in the annual report. We help our clients understand the magnitude of impact that a change can have and help them strategize on how to manage any regulatory implications that result.


Product Lifecycle Management

Generally speaking, the period of time before authorization or approval of a new drug is referred to as the Development Phase. Product Lifecycle Management (PLM) occurs after authorization and is the process of managing the entire post-approval lifecycle of a drug product after manufacture and launch. PLM has four stages: introduction, growth, maturity and decline. Almost from the moment of commercial approval, change is inevitable. The sponsor has a duty to keep the FDA informed of all changes to the original basis of approval. While all changes are important, those that impact the CMC section or product labeling may have the most consequences. Being aware of when and how to inform the FDA of such changes relative to implementing them is of utmost importance.

Depending on the scope of change and its impact to human health and safety, it may be necessary for the drug sponsor to receive FDA approval before making the change. Anticipating regulatory implications for CMC-related PLM changes ahead of time can result in shorter FDA approval times. Whether it’s a change needed to comply with new regulations, replace or add a new vendor, maintain, improve or expand manufacturing capacity, or even to add a new indication to the product label, the FDA will need to be notified.


Here are some examples of what we do:

  • Assess PLM plans using a scientific and risk-based approach to identify regulatory roadblocks and implications before moving ahead
  • Evaluate impact of the change to regulatory status (i.e., SUPAC)
  • Fashion the best regulatory strategy to “bundle” multiple changes when they are planned to be implemented simultaneously
  • Outline alternative phased-in implementation plans whereby a client can obtain FDA approval, if required, in a shorter time period
  • Ensure the PLM program complies with FDA and ICH standards


US FDA Presentation: “Lifecycle Management of Drug Products: FDA’s Perspective” DOWNLOAD

US FDA Guidance Document: “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” DOWNLOAD

US FDA Office of Pharmaceutical Quality Overview: “Pharmaceutical Quality Oversight” DOWNLOAD

Sample Engagements

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Provided regulatory strategy support to an Eastern European biosimilar company interested in obtaining USFDA approval of an EMA-approved biosimilar. All clinical studies were conducted ex-US. Assembled a cross-functional team, including clinical development and compliance experts, and successfully recreated informed consent for all clinical trials. Had a successful type B, face-to-face FDA meeting whose guidance was to do a bridging study in the US. The bridging study is now complete and being analyzed.

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Provided product life cycle, management regulatory and clinical development support to a US specialty pharma company seeking to revitalize its orphan designated oncology drug portfolio. Proposed a label expansion strategy whereby client could conduct new studies using special protocol assessment “SPA” option and potentially obtain FDA approval of two additional orphan indications. Support has involved FDA meetings, sourcing CROs and clinical development plans for clinical studies.

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A not-for-profit (NFP) Women’s Health Pharmaceutical company’s leading branded product’s patents were to expire within the next few years. The company’s Board tasked the leadership team to come up with a defensive lifecycle management strategy. Ayd Group was retained to develop a justification for them in the event they decided to expand operations to include a generic drug business unit. After a lengthy and complex process that factored in the company’s mission-statement, it was determined that generic market entry was feasible. The company would continue to focus on developing additional branded products, but would now have a business unit focused on complementary generic drugs focused on women’s health. Ayd group delivered a detailed evaluation report. We provided specific recommendations on what types of generic products their portfolio should include and what channels are best suited for marketing, sales and distribution. We also were able to determine who their competition is likely to be and described how they would need to transform from an internal perspective to be competitive.

Identify the Regulatory Implications for CMC-related PLM Changes before they Cause Delays.

If your PLM strategy involves changes needed to comply with new regulations, replace or add a new vendor, maintain, improve or expand manufacturing capacity, or expanding an existing indication, we can help support your plans.

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