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FDA Sends Info on Tropical Disease Vouchers to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget pertaining to a g...

Comments Sought on Safety Reporting, Electronic Submissions

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Federal Register Notice: FDA seeks comments on a proposed collection of information on the FDA Electronic Submission Gateway and t...

New Claims for Meridian BioSciences illumigene Pertussis Test

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FDA clears a Meridian Bioscience 510(k) for new claims for its illumigene pertussis molecular amplification test.

Guidance on Biosimilar Sponsor Formal Meetings

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Federal Register Notice: FDA releases a guidance: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Ap...

Regen BioPharma Gives FDA More Data on HemaXellerate

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Regen BioPharma submits data and responses to questions posed by FDA regarding its IND for HemaXellerate, a cellular drug designed...

Positive Results in Gilead Zydelig Study

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Gilead says its Phase 3 study of Zydelig combined with bendamustine and rituximab for treating patients with relapsed chronic lymp...

FDA Orders Mfr. Pediatric Studies of Contrast Media

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FDA says it is requiring manufacturers of iodinated contrast media to study the potential for infants to develop underactive thyro...

Another CDRH Letter Challenges Marketing of Test for Consumers

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FDA continues its crackdown against laboratory-developed test makers, sending a letter to HarmonyX about its tests for antiplatele...

Bernie Sanders Grills Califf on Industry Ties

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U.S. presidential hopeful Bernie Sanders (I-VT) grills FDA commissioner-nominee Robert Califf about his relationship with the drug...

Feds Coordinate Dietary Supplement Enforcement

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Several federal agencies announce coordinated enforcement efforts against a number of dietary supplement manufacturers.