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Precision BioSciences to Meet with FDA on Azer-Cel

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Precision BioScience says it will meet with FDA in June to discuss a regulatory way forward through a Phase 2 trial for its azer-c...

Groups Want Regulation of Lab-Developed Tests

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Sixteen advocacy organizations urge FDA to regulate laboratory-developed tests if Congress fails to produce a strong bill.

Junshi Bio Inspection to Advance Toripalimab BLA

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FDA completes a previously delayed pre-licensing inspection of China-based Shanghai Junshi Biosciences breakthrough cancer drug to...

FDA/EU MRA Now Includes Animal Inspections

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FDA and the European Union agree to expand the scope of the U.S.-EU mutual recognition agreement to include inspections of veterin...

FDA to Permit In-Person End-of-Phase 2 Meetings

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FDA says that beginning 6/12 it will expand in-person industry meetings to include requests for Type B End-of-Phase 2 requests at ...

FDA Proposes 1-Page Patient Medication Information

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FDA proposes a regulation to replace the current Medication Guides with a one-page Patient Medication Information sheet.

Violations at Advanced Compounding Solutions

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FDA warns Woburn, MA-based Advanced Compounding Solutions about multiple violations in its production of unapproved and misbranded...

Priority Review for BMS Lung Cancer Drug

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FDA accepts for priority review a Bristol Myers Squibb NDA for repotrectinib and its use for treating patients with ROS1-positive ...

Blue Earth PET Imaging Drug Approved

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FDA approves Blue Earth Diagnostics Posluma (flotufolastat F 18) injection, a prostate-specific membrane antigen-targeted positron...

Concerns with Macular Degeneration Guidance

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A developer of drugs to treat neovascular age-related macular degeneration raises issues with an FDA draft guidance on developing ...