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FDA Ordered to Speed U.S. Drug Manufacturing

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President Trump signs an Executive Order requiring FDA to take steps to increase domestic drug manufacturing.

Vinay Prasad Tapped as New CBER Director

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FDA appoints University of California, San Francisco professor Vinay Prasad to serve as CBERs new director, replacing Peter Marks,...

BIMO Inspection e-Submission Requirements Outlined

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An FDA Webinar discusses drug study information in NDAs/BLAs that will need to be electronically submitted in a certain format to ...

RM Pharma Gains Low-Dose HemiClor Approval

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FDA approves an RM Pharma 505(b)(2) for HemiClor (12.5 mg chlorthalidone) tablets for treating hypertension in adults.

Clinical Trials for Covid Boosters: Makary

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FDA commissioner Martin Makary reiterates that he wants to see clinical trials for new Covid vaccine boosters.

Teleflex Gains Expanded Use on QuikClot Device

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FDA clears a Teleflex 510(k) for an expanded indication for its QuikClot Control+ Hemostatic Device to include all grades of inter...

Experts Dismiss FDA Drug Development Tools Program

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Genentech researchers say FDAs Drug Development Tools Qualification program has had a very limited impact on development programs....

Lab Test Ruling Could Apply to AI at FDA: Researchers

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Public health researchers warn about the broader impacts to emerging technologies (e.g., artificial intelligence) in a March court...

ImmunityBio sBLA Filing Refused on Expanded Indication

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FDA sends ImmunityBio a refusal to file letter for its recent supplemental BLA submission seeking approval for Anktiva plus Bacill...

Capricor Therapeutics Passes Mid-Cycle Review

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Capricor Therapeutics says it has completed an FDA mid-cycle review meeting on a BLA seeking approval for deramiocel and its use i...