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Developmental proposals “may be more convincing,” if the drug is shown to be safe and effective in the treatment of other relevant diseases, the agency said. Read More
Seniors covered by Medicare Part D are paying more for generic drugs even though the market prices remain stable, according to new research by Avalere, a healthcare consulting firm. Read More
The FDA released guidelines for developing drugs for prophylaxis of inhalational anthrax, saying applications will be reviewed through the Animal Rule pathway due to safety and ethical concerns about human trials. Read More
In an alert that cited both safety and efficacy concerns, the FDA said it would pull over-the-counter oral benzocaine products from the market unless manufacturers discontinue their sale as teething products. Read More
Citing efficacy and other concerns, a joint FDA advisory committee voted 18-1 not to recommend approval of Insys’ buprenorphine spray for acute pain. Read More
The report suggests establishing arrangements that permit data sharing and improved communications among applicants, registry holders, marketing authorization holders and regulators. Read More