Now Available: The Office of Generic Drugs 2021 Annual Report - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. Now Available: The Office of Generic Drugs 2021 Annual Report Today, the Food and Drug Administration published the 2021 Office of Generic Drugs (OGD) Annual Report.   Generic drugs play a vital role in facilitating access to lifesaving medicines and remain a considerable public health priority for FDA. In 2021, with the new realities and unique challenges created by another year of the pandemic, OGD staff innovated and collaborated to keep the generic drug program on course and moving forward.  FDA approved hundreds of abbreviated new drug applications (ANDAs), thousands of application supplements, and funded approximately $20 million in generic drug science and research programs. We prioritized assessment of generic drug submissions for potential treatments and supportive therapies for patients with COVID-19, including more than 75 original ANDAs, some in record time, along with more than 1,200 supplemental approvals. OGD issued 148 product-specific guidances (54 of which were for harder-to-develop complex drug products) to relay the agency's current thinking on the most appropriate methodology and evidence needed to support the development of specific generic drugs. As of December 31, 2021, nearly 1,950 of these guidances can be found on FDA's website at Product-Specific Guidances for Generic Drug Development.   Additionally, the continued implementation of the Competitive Generic Therapy (CGT) program helped us reach a milestone in 2021 – approving 100 ANDAs designated as CGTs. The CGT pathway for generic drugs helps incentivize the entry of drugs with "inadequate generic competition" to the market. This milestone is a sign the program is achieving what was hoped – the development and market availability of safe, effective generic drugs in areas of the market that previously had little to no competition.  These and other accomplishments are also highlighted in the just-published FDA Voices article. Despite the challenges, 2021 marked another accomplished year for the generic drug program as the agency continued its commitment to increasing treatment choices and improving access to affordable medicines for the American public. View the full OGD 2021 Annual Report here.  This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA