FDA

The United States Pharmacopeia (USP) appreciates the opportunity to provide comments on a potential FDA novel excipient review program. USP is supportive of a novel excipient review program. Establishing new pathways for the development and regulatory review of novel excipients is critical in…
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Innovation drives progress in the development of new drugs and therapeutic biological products. 48 new drugs and biological products were approved by the FDA last year, which means new treatment options for patients and considerable advances in health. The majority of these new drugs…
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From innovative leaps in cancer diagnosis and treatment to the growing force of artificial intelligence in aiding medical discovery, the 2010s was a ground-breaking decade for the life science industry. We have seen the steady rise of targeted and personalised medicines, and advancements in genetic…
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Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create…
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The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. The FDA updates this list every six months (in June…
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In its continuous endeavor to bolster the competitiveness of the generics market, the US Food and Drug Administration (FDA) updated its list of ‘off-patent, off-exclusivity drugs without an approved generic’. This update is part of FDA’s initiative to improve transparency and encourage the…
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The US Food and Drug Administration (FDA) has released draft guidance for public consultation on the use of the Inactive Ingredient Database (IID). The document is intended to provide information on how to use the IID when choosing inactive ingredients. The guidance describes the Food and Drug…
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A BioPharma Dive article The Food and Drug Administration's top drug regulator sharply criticized the current clinical trial regime, calling for industry to embrace more collaborative studies. "I believe the clinical trial system is broken," said Janet Woodcock, who has worked at the agency…
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12. August 2018 The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. In concertwiththe method revamp, the agency introduced a multiyear…
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