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The agency is revoking requirements regarding inactivated influenza vaccine, allergenic products and the detection of extraneous toxic contaminants. Read More
The FDA has permanently barred an Arlington, Va., distributor from doing business in the U.S. after he was convicted of two felonies for selling counterfeit products. Read More
Eli Lilly’s lung cancer drug necitumumab improved overall survival when used with two combined chemotherapies, but caused a small uptick in sudden deaths, the FDA says in a preliminary review issued Tuesday. Read More
After nearly 25 years of trying to reach biologics manufacturer Chembiomed but getting no response, the FDA today revoked the Canadian firm’s license. Read More
The FDA is offering a four-month grace period to retail and hospital pharmacies that do not act as wholesale distributors to electronically exchange drug transaction information. Read More
The International Academy of Compounding Pharmacists is urging Congress to require the FDA to revise a memorandum of understanding outlining how states should regulate small compounders, saying the 30 percent a month limit on units sent to other states is unfair and unworkable. Read More
With more than 80 percent of APIs coming into the U.S. from foreign sites, FDA is stepping up its enforcement activities to better manage global supply chains. At the same time, India and China are also expanding their inspection teams. Read More