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FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
Elbasvir/grazoprevir, sold under the brand name Zepatier, is a fixed-dose combination for the treatment of hepatitis C, containing elbasvir (an inhibitor of hepatitis C virus's NS5A protein) and grazoprevir (an NS3/4A inhibitor). It is used to treat chronic hepatitis C virus (HCV) genotypes 1 or 4 infection in both treatment-naïve and ...
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
Here’s who needs to check their medicine cabinets. Home & Garden. Lighter Side
The agency's decision has no impact on the approved indication for the vaccine in the U.S. for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of ...
Robert F. Kennedy Jr.'s personal attorney previously petitioned the Food and Drug Administration to revoke its approval of a polio vaccine, highlighting an influential Kennedy ally who, sources ...
FDA Current Good Manufacturing Practices: 2006 Mylan [20] $465 million Misclassification under the Medicaid Drug Rebate Program: EpiPen (epinephrine) False Claims Act: 2006 Schering-Plough [21] $435 million Off-label promotion, kickbacks, Medicare fraud Temodar, Intron A, K-Dur, Claritin RediTabs: False Claims Act, FDCA 2004 [22] Pfizer $430 ...
Flu vaccines used during the flu in 2009. This is a list of vaccine-related topics.. A vaccine is a biological preparation that improves immunity to a particular disease.A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins.