Once a year, the Generic Drugs Forum was held on April 28 - 29, 2021 by the FDA Office of Generic Drugs (OGD). (1) OGD is the world leader in the science and regulation of generic drugs, serving an essential role in advancing FDA’s public health mission, and ensuring high-quality, affordable generic drugs are available to the American public.
There was a lot of valuable information presented at this 2-day event， which offered practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) review process (2), which is an excellent opportunity to reach the largest assemblage of participants from the Generic Drugs Community and discussed directly with FDA OGD officials.
This forum is also particular helpful for the consultants, regulatory affairs professionals, or contractors with an emphasis on those who plan to submit an ANDA or are in the process of submitting an ANDA, involved in generic drug development, work on bioequivalence, stability, dissolution and impurity testing and prepare regulatory submissions. There were numerous presentations focused on various aspects from pre-ANDA, drug development, post-marketing and global generic drug affairs program support for the generic drug program during the sessions.
I hereby would like to share some highlights of the Generic Drug Forum 2021 with our colleagues. As one of clean room suppliers, Pharmasource is willing to share information with you.
First of all, FDA OGD officials provided a significant amount of review information and suggestions for success in ANDA submission and approval during the COVID-19 pandemic. Some presenters provided their experiences and 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.
Secondly, like most organizations around the world, the FDA OGD experienced unprecedented and unique challenges during the COVID-19 public health emergency. FDA OGD quickly pivoted to prioritizing the assessment of generic drug submissions for products that could help address COVID-19 as the top priority. In addition to FDA emergency response to the COVID-19 pandemic, OGD and the entire generic drug program maintained FDA’s rigorous standards for evaluating non-COVID-19 products based on quality data and sound science.
Thirdly, OGD identified and pursued effective tools and strategies to aid in the fight against COVID-19 pandemic and created a new system for identifying generic drugs that are critical to the treatment of patients with COVID-19 and subsequently took regulatory and scientific action to accelerate review of those products. This new system included establishing the infrastructure to rapidly complete tasks and resolve review issues in support of taking timely actions on critical generic drugs used in the pandemic.
OGD also worked diligently to support manufacturers of approved generic drugs who needed to make changes to manufacturing processes or facilities to address disruptions caused by the COVID-19. These products included antibiotics, sedatives used in ventilated patients, anticoagulants, and pulmonary medications, among others.
As Director of Office of Generic Drugs (OGD), Dr. Sally Choe showed that OGD has prioritized assessment of over 50 ANDAs, and more than 800 supplemental applications were approved for drug products used to treat patients with COVID-19 pandemic in FY 2021. Dr. Choe also noted that, in FY2020 alone, 32 new or revised product-specific guidances (PSGs) introduced an in vitro option to demonstrate bioequivalence. She emphasized such options provided a lower regulatory hurdle while at the same time provides the assurance that generic drug products are indeed bioequivalent. In the prescription drug market, OGD helped increase competition by approving or tentatively approving 948 ANDAs, including 72 first generics approv...
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