Nov. 5, 2012 | Vol. 44 No. 44 | Full Issue in PDF Format
SEATTLE — The FDA’s Office of International Programs (OIP) is exploring development of a single, global recall system that would encompass all domestic and international recalls.
Rep. Ed Markey (D-Mass.) introduced a bill Friday that would force larger-volume compounders to register with the FDA as drug manufacturers.
Ameridose is recalling all of its unexpired product as an ongoing FDA inspection of its Westborough, Mass., facility has raised sterility concerns.
Bayer HealthCare and Onyx Pharmaceuticals have won priority review for Stivarga to treat metastatic and/or unresectable gastrointestinal stromal tumors.
The FDA has shot down Cornerstone Therapeutics’ low-sodium drug lixivaptan for both its proposed indications.
The New England Compounding Center (NECC), at the heart of a nationwide fungal meningitis outbreak, dropped the ball after seeing early signs of unacceptable levels of microbial contamination, the FDA says.
The FDA has handed a warning letter to the Memorial Hospital of South Bend institutional review board (IRB) for failing to adequately protect child participants in clinical trials.
UCB plans to submit marketing applications for Cimzia in psoriatic arthritis and axial spondyloarthritis (AxSpA), including ankylosing spondylitis (AS), to the FDA and EU by the end of the year.
Teva plans to launch its orphan chronic myeloid leukemia (CML) drug Synribo by mid-November after getting accelerated approval Oct. 26.
Teva’s ascending-dose, extended-regimen oral contraceptive Quartette is effective at preventing pregnancy and has a comparable safety profile to other oral birth control pills, the company said.
Watson Pharmaceuticals was dealt a blow when the FDA denied its formal dispute resolution request (FDRR) seeking approval for its progesterone vaginal gel.
BioCryst Pharmaceuticals has decided to pull its IND for a new hepatitis C (HCV) drug after the FDA raised concerns about the drug’s toxicity profile.
Titan Pharmaceutical has submitted an NDA seeking priority review of its Probuphine subcutaneous implant to treat adult opioid dependence.
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