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 …
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 …
Sun Pharma Draws Warning Letter for Multiple Quality Problems
WEBJanuary 13, 2023. Indian generics company Sun Pharmaceutical Industries took another hit from the FDA, receiving an FDA warning letter after the company failed to adequately address the agency’s concerns over lapses in aseptic procedures, inadequate media fills, poorly designed and ventilated cleanrooms, and flaws in vial-filling machinery.
Edge Pharma to Stop Producing and Distributing Compound Drugs
WEBJun 15, 2022 · Edge Pharma, a compounding pharmacy based in Colchester, Vt., has entered into a consent decree in a federal court to cease manufacturing and distributing drugs until it takes steps to get back into compliance with FDA requirements. In a May 20 complaint in the U.S. District Court for the District of Vermont, the Department of Justice …
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 ISSUES APPROVABLE LETTER FOR NOVARTIS' GALVUS …
WEBFebruary 26, 2007. Novartis announced it has received an approvable letter from the FDA for Galvus (vildagliptin), which is being reviewed as a new once-daily oral treatment for patients with Type 2 diabetes. An approvable letter means the FDA is prepared to approve an investigational medicine but that certain conditions must be met prior to ...
FDA Provides Draft Guidance for Using ctDNA Biomarker in
WEBMay 3, 2022 · The FDA has released a draft guidance for cancer drug sponsors on the design of clinical trials that use circulating cell-free plasma-derived tumor DNA (ctDNA) as a biomarker. Because ctDNA can be measured in the bloodstream, the biomarker can be used in the early stages of a clinical trial, including to detect a targetable alteration, to …
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.
WEBAug 6, 2009 · 10 Common Mistakes/“Tips” for Responding to the Warning Letter. Know your Audience The Response is your First Impression Understanding the Observation/Violation Establish a Comprehensive Corrective Action Plan. • Following Through on CAP. Address the Specific Observation Identify Root Cause Solutions (Systems) Consider …
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