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The FDA clarified the agency’s interpretations of what is meant by “suspect” and “illegitimate” products in the Drug Supply Chain Security Act (DSCSA) in a final guidance released Thursday. Read More
The FDA’S Antimicrobial Drugs Advisory Committee (ADAC) voted 16 to 1 on Thursday in favor of Pfizer’s antiviral Paxlovid (nirmatrelvir and ritonavir) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Read More
The FDA dinged Dunagin Pharmaceuticals’ Rogers, Ark., drug manufacturing facility for its water system, its drug manufacturing and equipment cleaning processes, and for other deficiencies observed during an Aug. 29 to Sept. 2, 2022 inspection. Read More
The FDA offers recommendations for using electronic systems, records and signatures in clinical trials, including advice on validation, in a draft guidance released Wednesday. Read More
Sponsors developing long-acting local postoperative anesthetics should consider including novel, clinically meaningful endpoints in their trial design, the FDA has said in new draft guidance. Read More
On Wednesday, the Biden administration released a list of 27 drugs and biologics whose prices are rising faster than the rate of the inflation, and thus whose manufacturers will owe a hefty fine to the Medicare Trust Fund in 2025. Read More