Now Available: The Office of Generic Drugs 2020 Annual Report Today, the Food and Drug Administration published the 2020 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 2020, even as the COVID-19 global pandemic resulted in new realities and unique challenges, OGD's work stayed the course to help make safe, effective, high-quality, and more affordable generic drugs available and accessible in the United States. The OGD Annual Report provides highlights of the generic drug program's 2020 accomplishments. Even with the unprecedented demands of the COVID-19 pandemic, OGD continued to exceed the majority of the performance goals for generic drug application assessments and other commitments. In 2020, OGD helped increase competition by approving or tentatively approving 948 Abbreviated New Drug Applications (ANDAs), including 72 first generics. These were relatively consistent numbers compared to recent years and speak to the continued strength of the overall generic drug program. FDA also approved 30 generics with the Competitive Generic Therapy (CGT) designation, including a quarterly record of 17 CGT approvals in the first quarter of fiscal year (FY) 2020. The OGD Annual Report outlines how OGD's strategic, proactive approaches to supporting generic drug development and assessment had a real impact for American patients. Throughout the year, FDA continued to take timely actions on COVID-19 and non-COVID-19 related ANDAs, advance policies and science and research efforts in support of generic drug development—particularly for hard-to-copy complex generics, and effectively communicate with industry to help improve the quality of generic drug applications. These and other accomplishments are also highlighted in the just-published FDA Voices article. Despite the challenges faced, 2020 marked another accomplished year for the generic drug program, as the agency continued to prioritize its commitment to increasing treatment choices and improving access to affordable medicines for the American public. View the full OGD 2020 Annual Report here. | 
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