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A group of lawmakers wants the FDA to strip Zogenix’s opioid painkiller Zohydro ER of its approval until the company creates an abuse-deterrent formulation of the product. Read More
The FDA has notified Biogen Idec that it needs more time to review its BLA for Alprolix after the drugmaker submitted additional data supporting the validation of a key manufacturing step. Read More
Baxter has issued another recall, this time for a single lot of the nitroglycerin 5 percent dextrose injection, a drug used for pre- and post-operative hypertension, congestive heart failure at the onset of heart attack and chest pain. Read More
Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More
Alexion’s recall and replacement of vials of its rare disease drug Soliris could cost the company between $10 and $25 million in the fourth quarter, the drugmaker says in an SEC filing last month. Read More
Sloppy investigations into various deviations such as hair in finished drug vials are outlined by the FDA in a Form 483 for OSO Biopharmaceuticals Manufacturing. Read More
The FDA chided OTC drugmaker Altaire for an inadequate response to numerous customer complaints of mold in the eye drop product carboxymethylcellulose sodium 0.5 percent ophthalmic solution, 30 mL. Read More
Merck KGaA’s Mexican subsidiary received a Form 483 for inadequately looking into a glass defect and not examining devices used in its products. Read More
A North Carolina pharmacy is recalling all of its sterile compounded drugs distributed within the Tar Heel State and ceasing production of sterile products altogether after an FDA site inspection. Read More
The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics. Read More