In 2020, the FDA approved 53 innovative drugs and 65 first imitation drugs

Figure: FDA Year-end Summary Approval of 53 Innovative Drugs During 2020, the FDA Medical Products Center continues to perform its normal basic responsibilities while focusing specifically on addressing the challenges of this public health emergency.
new crown, the FDA has issued new guidelines for conducting clinical trials during the new crown to facilitate a shift in action to protect participants and maintain data integrity.
FDA's New Drug Review Center (CDER), in collaboration with the Center for Biological Evaluation and Research (CBER), has developed an accelerated coronavirus treatment program designed to help bring new coronavirus drugs to market as quickly as possible.
Currently, there are more than 590 new crown-related drug development programs in the planning phase, the FDA has reviewed more than 390 clinical trials, and through the Emergency Use Authorization (EUA), eight drug therapies have been approved during the new crown pandemic, of which the FDA has approved the first drug to treat certain new crown patients.
By 2020, CDER approved 53 innovative drugs and re-approved new uses for many approved drugs that can be used to treat a variety of medical diseases, including infectious, neurological, cardiovascular, endocrine and autoimmune diseases, rare diseases and cancers.
of these novel approvals, 31 (58 percent) help patients with rare diseases, many of which were not previously FDA-approved drugs.
Of the many innovative drugs and biological products approved in the past year, 16 specifically involve cancer treatments, including RET fusion-positive lung cancer, retrial multiple myeloma, initial treatment of MSI high colon cancer, and resuscable gastrointestinal mesothelioma.
of these, a review was conducted by the Orbis Program of the Center of Excellence in Oncology, which provides the FDA and its international partners with a framework for simultaneously reviewing oncology drug applications.
FDA, which approves 65 first-generic drugs, has also continued important work to ensure cost savings and support for essential drugs.
As of November 30, 2020, the FDA has approved or initially approved more than 800 generics, including 65 first-generic drugs, such as: newly approved drugs for the treatment of severe hypoglycemia (very low blood sugar);
Photo: On December 28, 2020, the FDA announced that it had approved the first generic drug for injectable glupaucose USP, which is also working to help improve patient access to insulin, and issued draft guidelines describing recommendations for simplifying methods to demonstrate biosimilarity and interchangeability of certain insulin products.
drug safety monitoring CDER has also taken action to remove a variety of drugs containing potentially carcinogenic nitrosamines from the market.
FDA announced its findings on the safety of sunscreens, and took steps to implement a new law that modernizes the way over-the-counter drugs (OTCs) are regulated; benzodiazepines must have stronger risk warnings; and nonsteroidal antioxidants require new safety warnings - inflammatory drugs.
FDA has issued guidelines to the industry to further help those who use the drug to identify and prevent health conditions in their facilities.
to address drug shortages, the FDA has made many decisions to address drug shortages.
, for example, the FDA has helped manufacturers extend the validity period, prioritized approvals for many generic drugs to alleviate shortages, and issued guidelines for the production of alcohol-based hand lotions to help increase supply.
CBER, which is working together to develop a vaccine to prevent new crowns, has been busy supporting the agency's response to the new crown pandemic for a year, with a focus on working with manufacturers to develop and market vaccines to prevent new crowns.
as part of this work, CBER has published two industry guides.
first guide, the Committee provided recommendations to sponsors on the scientific data and information needed to support the development and licensing of safe and effective vaccines to prevent new crowns.
in its second guide, vaccine sponsors are provided with recommendations for scientific data and information that will support the issuance of ESAs for new crown vaccines, including chemical, production and control information, non-clinical and clinical data, and regulatory and administrative information.
recently, CBER approved two ESAs for the new crown vaccine, while other new crown vaccines are under development.
the FDA convened two meetings of the Advisory Committee on Vaccines and Related Biologics (VRBPAC) to seek the views of independent scientific and public health experts on each vaccine candidate, underscoring the FDA's commitment to the data and information needed to be as open and transparent as possible.
these inputs, coupled with a careful and thorough assessment by CBER professional scientists, will give the public and the medical community confidence in these vaccines, which meet the FDA's stringent standards for safety and ability.
to advance the FDA's public health mission globally Through global engagement, the FDA is advancing its important public health mission, which is another reminder of the coverage of the FDA's work.
FDA, through its cooperation in the response to the new crown pandemic, has recognized the importance of the FDA's global engagement, including the participation of the FDA's European office, with the support of the International Drug Control Alliance, in the first global regulatory workshop on the new crown vaccine to discuss strategies to promote the development of the SARS-CoV-2 vaccine and, to the extent possible, to promote regulatory convergence.
same year, CVM incorporated veterinary drugs into the GMP Mutual Recognition Agreement (MRA) between the FDA and the European Union, enhancing the use of each other's expertise and resources for veterinary drug inspections and increasing efficiency.
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