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CGMP Deviations at Mexican Signa Facility

[ Price : $8.95]

FDA warns Canadas Signa SA de CV about CGMP violations at its Toluca, Mexico, API manufacturing facility.

Centurion Medical Products Kit Issues

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FDA warns Centurion Medical Products about manufacturing and distributing unapproved medical device/drug combination sterile conve...

Meeting on User Fee FDA-Sponsor Communications

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Federal Register notice: FDA announces an 8/11 public meeting entitled Independent Third-Party Assessment of IND FDA-Sponsor Commu...

FDA Panel to Review Mesoblast BLA

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Federal Register notice: FDA announces an 8/13 Oncologic Drugs Advisory Committee meeting to review a Mesoblast BLA for Remestemce...

Pieris Pharma Study of Cancer Drug on Hold

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FDA places a Pieris Pharmaceuticals Phase 1 study of cancer drug PRS-343 on partial clinical hold while the company conducts an ad...

FDA Withdraws Approval of 10 ANDAs

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Federal Register notice: FDA withdraws approval of 10 ANDAs from multiple applicants after they notified the agency that the drug ...

Draft Guide on Appealing Mammography Actions

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Federal Register notice: FDA makes available a draft guidance entitled Appeal Options Available to Mammography Facilities Concerni...

Cannabis Research Quality Guidance

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FDA issues a draft guidance on quality considerations for clinical research related to developing drugs containing cannabis or can...

New COA Grant Funding Opportunity

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FDA offers a second funding opportunity to develop core sets of clinical outcome assessments for four areas.

FDA Not Cutting Vaccine Standards: Companies

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Drug company executives try to reassure a House committee that FDA will not lower its standards to approve a Covid-19 vaccine.