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Human Drugs

Comments on Breakthrough Therapy Recission Draft

Three stakeholders comment on an FDA draft guidance on rescinding breakthrough therapy designations.

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Human Drugs

Imbruvica Pediatric sNDA Approved by FDA

FDA approves a Pharmacyclics supplemental NDA for Imbruvica (ibrutinib) for certain pediatric patients over one year of age with chronic graft versus ...

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Human Drugs

FDA Releases 3 Drug Safety-Related Label Changes

FDA publishes drug safety-related labeling changes for Gleevec and Rapamune.

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House Committee on Trump's Covid Pressure on FDA

A House Select Subcommittee on the Coronavirus Crisis report details evidence of what it sees as inappropriate Trump administration pressure on FDA ov...

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Federal Register

Info Collection on Humanitarian Use Devices

Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Devices; Humanitarian Use Devices (HUD) 21 CFR part 814...

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Federal Register

Device Labeling Info Collection

Federal Register notice: FDA seeks comments on an information collection revision entitled Medical Device Labeling Regulations.

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Human Drugs

Amazon Warning Letter Raises Questions: Attorneys

Two Mintz attorneys discuss questions raised by a recent FDA Warning Letter involving the Amazon.com fulfillment service that delivered unapproved dru...

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Biologics

Pull IPOL Polio Vaccine Until Better Trial Held: ICAN

The Informed Consent Action Network says FDA should withdraw approval of the IPOL polio vaccine until adequate clinical trials demonstrate its safety.

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Human Drugs

FDA Denies Petition Seeking Freeze on Russia-based Applications

FDA denies a citizen petition seeking a freeze on all regulatory requests from pharmaceutical and medical device companies headquartered in Russia or ...

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Medical Devices

Surgaligns Cortera Spinal Fixation Device Cleared

FDA clears a Surgalign Holdings 510(k) for its Cortera Spinal Fixation System.