There were numerous presenters in the morning session on April 28, 2021.  Below are some of the highlights.

Dr. Sally Choe, Director, Office of Generic Drugs (OGD) noted that OGD has prioritized assessment of over 50 ANDAs and more than 800 supplemental applications in FY 2021 to meet the needs associated with the Covid-19 pandemic.

She noted that, in FY2020 alone, 32 new or revised product-specific guidances (PSGs) introduced an
in vitro option to demonstrate bioequivalence.  Such options provide a lower regulatory hurdle while at the same time provides the assurance that generic drug products are indeed bioequivalent.

Since the inception of Hatch-Waxman’s in 1984, drug product complexity has evolved as newer and unique products are developed and approved. Complex drugs introduce new and challenging issues as they progress in complexity from simple, small molecules to products that have complex active ingredients, dosage forms, formulations, or routes of delivery, as well as products that are drug-device combinations.  The assessment of these complex products requires special assessments of attributes that were not found with many of the original small molecule solid oral dosage forms that were originally available for competition at the inception of the Hatch-Waxman Amendments.

FDA has forged contracts and relationships with outside entities, including universities and research organizations. Such collaborations and FDA’s own internal expert working groups have enabled the approval of many complex products.

A few of the complex ANDA products approved by OGD during FY 2021 include:

  • Glucagon for injection (RLD: Glucagon)
  • Ferumoxytol injection (RLD: Feraheme)
  • Imiquimod cream (RLD: Zyclara)
  • Linaclotide capsules (RLD: Linzess)
  • Loteprednol etabonate ophthalmic gel (RLD: Lotemax)

Larry Lee, Deputy Director of Science, Office of Product Quality provided some highlights from his Office’s 2020 actions. He noted that:

  • 153 pre-approval inspections avoided using alternative tools due to COVID-19 travel restrictions
  • Over 95% of applications were acted on by their user fee goal date
  • 293 expedited quality assessments to avert or mitigate drug shortages
  • Over 10,000 approved application supplements

A number of presenters provided their views on other issues, including the importance of OGD findings on data integrity in clinical study data, bioequivalence data, pharmacokinetic data and toxicology data in GLP and non-GLP studies. The issue with data integrity impacts not only the applicant, but the CRO and the reputations of all partners involved.  It also adversely impacts the FDA, as the time it must take to evaluate and mitigate the impact of data integrity concerns can delay the availability of generic drug products to the public.  Some of the common types of data integrity issues that FDA encounters were discussed.

Dr. Victoria Keck, Toxicologist from the OGD’s Division of Clinical Review responded to a question asking if an ANDA can be delayed because a GLP inspection is requested during the toxicology review. She explained that this can be a big problem, especially if the initial completeness and acceptability review of the ANDA does not flag the need for toxicology review, as the consult for review may then come late in the review cycle and, if a GLP inspection is required, then this could either delay the goal date or require a complete response letter to inform the applicant of the need for the inspection’s completion.

Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, spoke about various policy issues facing OPQ and OGD and outlined the following quality policy priorities for FY 2021:

Guidance – draft/revised draft

  • ANDAs: Stability Testing of Drug Substances and Products Questions and Answers
  • Quality and Stability Testing of Drug Substances and Drug Products for NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products
  • Inspection of Injectable Products for Visible Particulates
  • Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and

Labeling Recommendations

  • Microbiological Quality Considerations in Non-Sterile Drug Product Manufacturing
  • CDER’s Program for the Recognition of Voluntary Consensus Standards (Final)
  • Proposed Rulemaking: Post Approval Changes to Approved Applications
  • Internal: Implementation activities associated with “alternate tools” used when inspections cannot be accomplished due to travel restrictions
  • Quality Management Maturity
  • International Harmonization


She also discussed the new subsection 510(j)(3) of the FD&C Act which added a requirement that persons who register drug establishments under section 510 must report annually the amount of each listed drug manufactured for commercial distribution.  In addition, she outlined new requirements under the CARES Act for risk management plans and various guidances issued during the Covid-19 response.


Jennifer A. Maguire, Acting Director, Office of Quality Surveillance, Office of Pharmaceutical Quality, discussed the surveillance activities that her office reviews.  Her office does not take enforcement actions but rather evaluates various data sets available to the Agency.  If there appears to be a concern from the data reviewed, the Office of Surveillance refers it to the Office of Compliance.  The types of data surveilled include but are not limited to:


  • Facility and Inspection Data
    • Registration and Listing
    • Inspection findings
    • Profile Class Codes, Imports, Business operations, etc.
  • Quality Defect Reports
    • Field Alert Reports (FARs)
    • Biological Product Deviation Reports (BPDRs)
    • MedWatch Reports
    • Recalls (Type I, II, III)
    • Consumer Complaints
    • Informants
  • Drug Quality Sampling and Testing Results
  • Application Data
    • Original and Supplements
    • Annual Reports


  • Quality Metrics (Future)
  • Quality Management Maturity (Future)
  • External Data
    • Foreign regulatory authority information
    • Public information – social media, consumer reviews (e.g.,, blogs, news outlets, etc.


There was a lot of good information presented this morning, and there is still time for you to register here for the forum for this afternoon’s session and for the sessions tomorrow.