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Comments Sought on Use Codeine for Analgesia

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Federal Register notice: FDA establishes a docket to solicit public comment on specific questions pertaining to the use of codeine...

Compounded Hormone Therapies Have Risks: National Academies

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A National Academies committee says compounded bioidentical hormone therapies are insufficiently regulated and pose a public healt...

Animal User Fee Info Collection Extension

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Federal Register notice: FDA sends to OMB an information collection extension for Reporting Associated With Animal Drug and Animal...

Concerns About AI in Radiological Imaging

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Two radiology professional societies say FDA is not ready to approve a pathway for authorizing autonomously functioning artificial...

Researchers List Needed Covid Vaccine Safeguards

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Three former FDA and HHS officials say there must be four safeguards in place to promote trust in any Covid-19 vaccine.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Homeocare Laboratories and Auro Pharmacies.

Exceptions to Labeling for Stockpiled Products

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Federal Register notice: FDA seeks comments on an information collection extension for Exceptions or Alternatives To Labeling Requ...

Novartis Settles Sham Speaker Programs for $678 Million

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The Justice Department says Novartis will pay $678 million to settle a whistleblower suit alleging that it operated a sham speaker...

CDER to Test Multiple Indication TV Ads

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The CDER Office of Prescription Drug Promotion proposes to test whether consumers are challenged by TV ads that promote more than ...

CDER Research on Transdermal Generic Evaluations

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A new FDA post discusses research by CDER statisticians who developed innovative and more efficient ways to evaluate transdermal a...