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WEBFeb 22, 2021 · The US Active Pharmaceutical Ingredient Infrastructure: The current state and considerations to increase US Healthcare Security “Keeping the Nation’s drug supply chain secure, robust, and resilient is essential for the national security and economic prosperity of the United States1.” I. Summary
Good Documentation: More Than Entering Data | 2014-08-13
WEBAug 13, 2014 · Good Documentation Practices are guided by five standards. These standards consist of truth, accuracy, completeness, legibility, and timeliness. Truth: This standard maintains that the person who completed the process or performed the task actually did the work—and completed the appropriate documentation. No signature stamps are to be used ...
WEBJurisdiction defined by the Federal Food, and Cosmetic Act (FDCA) and the Health Service Act. Human food, including dietary supplements and color additives and OTC medications, and APIs Vaccines, blood products, and biologics Medical devices Radiation-emitting products Cosmetics Animal food, feed, and veterinary medicines Tobacco products.
Federal Judge Tells FDA it Must Make Public 55,000 Pages a
WEBJan 7, 2022 · A federal judge in Texas has ruled that the FDA must by the end of this month make public 12,000 pages of the data it used to make decisions about approvals for Pfizer/BioNTech’s COVID-19 vaccine — and then release 55,000 pages every 30 days after that until all 450,000 requested pages are public. The request for FDA’s Pfizer/BioNTech data flows from an August 2021 Freedom of Information ...
WEBSep 16, 2019 · FDA publishes these product-specific guidances to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, affordable generic drugs. These guidances are published in an incremental manner and listed below in alphabetical order according to the active ingredient's name.
FDA Warns Online Pharmacy for Selling Drugs That Require a REMS
WEBJanuary 9, 2023. The FDA sent a warning letter to Global Pharmacy Plus, an internet pharmacy, concerning the company’s marketing of generic versions of the immunosuppressant drugs mycophenolate mofetil and tacrolimus, both of which carry Black Box warnings and must only be distributed under an approved Risk Evaluation and Mitigation Strategy ...
Regulatory Affairs - FDAnews
WEBSeptember 11, 2024. This excerpt is from the management report titled “Risks of Social Media Communication: A Guide to FDA and FTC Enforcement,” based in part on a webinar from FDAnews, A WCG Company, presentation by Kellie Combs and Joshua Oyster, partners in the Life Sciences Regulatory and Compliance practice group of …
USA-Made KN95 Face Mask Cleared | 2022-02-08 | FDAnews
WEBFebruary 8, 2022. Lindon, Utah-based PuraVita Medical has received the FDA’s 510 (k) clearance for its domestically made medical-grade KN95 face masks. “Our KN95 masks are the only KN95s in the world that are FDA 510 (k) approved, ASTM Level 3 and Made in USA,” the company said. ASTM Level 3 is the FDA's highest rating for medical and ...
FDA Grants EUA To iHealth's COVID-19 Self-Test Kit
WEBNovember 12, 2021. iHealth Labs has received the FDA’s Emergency Use Authorization (EUA) for over-the-counter sale of its COVID-19 Antigen Rapid Test. iHealth’s current production capacity is 100 million COVID-19 tests per month, but it will increase that to 200 million tests a month starting in January, according to Jack Feng, partner of ...
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