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TXT Info Collection on OTC Drugs as GRASE [108 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for additional criteria and procedures for classifying over-the-counter drugs.
07/30/2020
 
 
TXT Vaccine EUA Would Follow Efficacy: Marks [2723 Words] [ Price : $8.95]
CBER director Peter Marks tells an online health summit that a Covid vaccine EUA could be approved within weeks after a vaccine meets efficacy requirements.
07/30/2020
 
 
TXT FDA Draft Guide on Endotoxin Limits [101 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.”
07/29/2020
 
 
TXT Rule on Animal Drug e-Submission Safety Reports [80 Words] [ Price : $8.95]
Federal Register notice: FDA issues a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drugs.
07/29/2020
 
 
TXT Guide on Multiple Function Device Products [100 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance on “Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff.”
07/29/2020
 
 
TXT Unit-Dose Expiration Dating Guidance [2661 Words] [ Price : $8.95]
FDA issues a guidance explaining when the agency will not take action regarding requiring stability studies for repackaged products and expiration dates under those circumstances.
07/29/2020
 
 
TXT Pregnancy, Lactation, Reproduction Draft Guidance [2747 Words] [ Price : $8.95]
FDA issues a draft guidance to help applicants comply with content and format requirements for drug label subsections on pregnancy, lactation, and people of reproductive potential.
07/29/2020
 
 
TXT Breast Cancer Endpoint Guidance [2768 Words] [ Price : $8.95]
FDA issues a guidance on using pathological complete response as an endpoint for accelerated approval of drugs to treat high-risk early-stage breast cancer.
07/29/2020
 
 
TXT Pacira Paying $3.5 Million for FCA Kickback Charges [2677 Words] [ Price : $8.95]
The Justice Department says Pacira Pharmaceuticals is paying $3.5 million to resolve a whistleblower charge that it provided kickbacks to doctors to induce them to prescribe its Exparel analgesic.
07/29/2020
 
 
TXT Neocis Yomi Edentulous Indication Cleared [187 Words] [ Price : $8.95]
FDA clears a Neocis 510(k) for a new Yomi edentulous indication for its robot-assisted dental surgery system.
07/29/2020
 
 
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