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Andrew von Eschenbach’s nomination to be the next FDA commissioner remains stalled as the agency’s efforts to reach a compromise with a prominent lawmaker over access to an ongoing clinical trial investigation have failed. Read More
Devicemaker Nose Breathe was cited for more than 16 violations of cGMPs for its orthodontic and positioning mouthpieces in a recent FDA warning letter. Read More
Bausch & Lomb’s MoistureLoc contact lens solution was cited as “adulterated” in a recent FDA warning letter, which followed an agency inspection that found the firm did not conform to GMP requirements. Read More
The FDA intends to issue a proposed rule on cGMPs for combination products next spring, a senior FDA official said at the Regulatory Affairs Professionals Society annual conference last month. Read More
Natren received an FDA warning letter for misleading information on its website and the labeling for its products Gy-Na-Tren Vaginal Health Solution and Life Start.
Lester Crawford, the former FDA com-missioner who abruptly left the agency two months after being confirmed, pleaded guilty to failing to disclose financial conflicts and making false statements, but is unlikely to spend more than a few months in prison, his attorney says. Read More
While controversy surrounds potential conflicts of interest among institutional review board (IRB) members, no one knows who owns the boards themselves. Read More