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In its continuing effort to step up post-pandemic enforcement activities, the FDA wrapped up 2023 by making public three Form 483s for as many Indian pharmaceutical manufacturers. Read More
The FDA is seeking input from a wide variety of stakeholders on a draft report on best practices for streamlining the development, dissemination and use of guidances. Read More
The company was also named in five other warning letters this year aimed at companies selling unapproved and mislabeled drugs via Amazon’s site. Read More
The FDA is seeking input on a new draft guidance intended to help manufacturers develop strategies for ensuring potency in human cellular or gene therapies (CGT). Read More
Over the past week, the FDA issued a final rule on direct-to-consumer prescription drug advertisements. The agency issued final guidance on development of drugs and biological products for rare diseases, direct-to-consumer promotional labeling and advertisements and, reformulating drug products that contain carbomers manufactured with benzene. Draft guidance was issued on potency assurance for cellular and gene therapy products and quality considerations for topical ophthalmic drugs. Read More
The FDA will kick off the new year under another possible threat of a shutdown because lawmakers have so far failed to agree on fiscal 2024 funding for the federal government and stopgap funding is set to expire on Jan. 19 — just over one week after the House and Senate begin the new session. Read More
The guidance was issued without inviting public comment due to “the immediate public health need to expedite the discontinuation of the use of these carbomers.” Read More
Research updates in this edition include drug successes for multiple myeloma, COPD, breast cancer and weight loss as well as disappointments in drugs for colorectal and endometrial cancer as well as hyperkalemia.Read More
Amazon was hit with its third FDA warning letter of the year last week, this time for selling unapproved and incorrectly labeled products that contain the active ingredient in erectile dysfunction (ED) drugs Cialis and Viagra. Read More
The drug was approved in 2018 to treat X-linked hypophosphatemia (XLH), a rare form of rickets characterized by low levels of phosphate in the blood. Read More