FDA inspections cause fear among some and apprehension amongst others. Such inspections often result in a disruption of activities and may result in a negative action taken by the federal government.
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...
U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how ...
When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view into the high-stakes discussions that decide whether a medicine will ever make ...
An FDA investigator prepares a test sample for IMS analysis from a shipment of dietary supplements that arrived at the Port of Buffalo in Buffalo, N.Y. (FDA photo) The outbreak of COVID-19 has called ...
While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal ...
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US FDA Inspection on Rise: Indian Pharma and Medical Devices Manufacturers Strengthen GMP Compliance
City, India, December 23, 2024: In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device manufacturers are enhancing their Good ...
After months of COVID-related delays, the FDA’s reviews of two China-made PD-1 cancer immunotherapies are finally moving forward. The FDA has scheduled a manufacturing inspection for Novartis and ...
The OTC eye drop products were marketed under the following brands: CVS Health, Leader, Rugby, Rite Aid, Target Up&Up, and Velocity Pharma. CVS, Rite Aid, and Target are in the process of removing the ...
Capricor Therapeutics announced that it has successfully completed the U.S. FDA's Pre-License Inspection of its San Diego manufacturing facility for its lead therapy candidate, Deramiocel, aimed at ...
The US Food and Drug Administration (FDA) has sent a warning letter to Abraxis BioScience, which manufactures the chemotherapy drug Abraxane (paclitaxel), citing ongoing contamination hazards since ...
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