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Federal Register

Comments Sought on Use Codeine for Analgesia

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

Human Drugs

Compounded Hormone Therapies Have Risks: National Academies

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

Federal Register

Animal User Fee Info Collection Extension

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

Medical Devices

Concerns About AI in Radiological Imaging

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

Biologics

Researchers List Needed Covid Vaccine Safeguards

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

FDA General

Latest FDA Warning Letters

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

Human Drugs

FDA Alert on BD Covid-19 Reagents

An FDA safety alert warns about an increased risk of a false positive result with Becton Dickinsons BD SARS-CoV-2 Reagents for the BD Max System test....

Federal Register

Exceptions to Labeling for Stockpiled Products

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

Novartis Settles Sham Speaker Programs for $678 Million

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

Marketing

CDER to Test Multiple Indication TV Ads

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