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Guide on Contact Lens Submissions

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance C...

Guide on Animal Studies for Devices

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled General Considerations for Animal Studies Intended to Evalu...

Cell, Gene Therapy Application Backlog Questioned

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The chair and ranking member of the House Energy and Commerce Health subcommittee ask CBER director Peter Marks for detailed infor...

Bipartisan Bill on Interchangeable Biologics

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Four U.S. Representatives introduce the Biologics Competition Act, a bipartisan bill that would order HHS to evaluate the process ...

GSK Will Seek Expanded Use for Jemperli

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GSK says it plans to submit a BLA supplement by 7/1 after reporting interim results from a Phase 3 trial investigating Jemperli (d...

Labeling Changes Approved for 2 Hedgehog Inhibitors

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FDA approves changes to labeling for two Hedgehog inhibitors covering musculoskeletal adverse reactions and creatine kinase monito...

Guide on Animal Studies for Devices

[ Price : $8.95]

FDA publishes a final guidance entitled General Considerations for Animal Studies Intended to Evaluate Medical Devices.

Under Protest, Brainstorm Resubmits BLA for NurOwn

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BrainStorm Cell Therapeutics says it has refiled a BLA under the agencys file-over-protest procedure for NurOwn, a stem cell thera...

FDA Resumes Generic Drug In-person Meetings

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FDA says that it is now resuming generic in-person face-to-face meetings with generic drug industry members in a phased-in approac...

Alternative 510(k) Pathway for Contact Lenses

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FDA makes available a final guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety and Pe...