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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Coupler Enterprises and HNC Products.

Tighter Covid Vaccine Approval Standards Coming: Report

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The Washington Post reports that FDA will issue a new guidance for Covid-19 vaccines that will tighten emergency authorization sta...

CGMP Violations at HNC Products

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FDA warns HNC products about significant violations of CGMP regulations in its production of OTC drugs.

Continuous Manufacturing and Counterfeit Devices Bills Pass

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The U.S. House passes two bills having wide implications for FDA in supporting Continuous Pharmaceutical Manufacturing and combati...

Final Rule Correction on Animal Drug e-Submission

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Federal Register notice: FDA corrects a 7/29 final rule requiring electronic submission of certain postmarketing safety reports fo...

Minor CRL for Hikmas Generic Advair Diskus

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Hikma says it expects final FDA approval of its ANDA for a generic form of GSKs Advair Diskus early next year.

FDA Priority Review for BMS Ide-Cel

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FDA says it will give priority review to a BLA submitted by Bristol-Myers Squibb and bluebird bio for their ide-cel, the first CAR...

FDA Launches Digital Health Center of Excellence

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FDA says it is launching a Digital Health Center of Excellence within CDRH.

Spineology Gains De Novo for OptiMesh

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FDA grants Spineology Inc. a de novo marketing authorization for its OptiMesh Expandable Interbody Fusion System.

Q&A Content Added to Clinical Trial Guidance

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FDA adds content to a question-and-answer appendix in its guidance entitled Conduct of Clinical Trials of Medical Products during ...