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IND Regulations Information Collection Revision

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Investigational New Drug Application Regulat...

Info Collection on HIV Test Complaint Logs

[ Price : $8.95]

Federal Register notice: FDA sends an information collection revision on medical device Class 2 special controls for human immunod...

FDA Sets BsUFA Enhanced Review Meeting

[ Price : $8.95]

FDA schedules a 3/22 virtual public meeting to discuss its final assessment of the BsUFA Program for Enhanced Review Transparency ...

FDA Publishes New Product-Specific Guidances

[ Price : $8.95]

FDA announces the publication of 30 new and 13 revised product-specific guidances to promote generic drug development.

Tillis Wants FDA, USPTO Patent Data Study

[ Price : $8.95]

Jones Day attorneys outline Sen. Thom Tillis request for an independent study of data on drug companies using the patent system to...

Tandem App Cleared for Bolus Insulin Dosing

[ Price : $8.95]

FDA clears a Tandem Diabetes Care 510(k) for bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app.

Companion Animal Antimicrobial Use Comments Sought

[ Price : $8.95]

Federal Register notice: FDA seeks comments about antimicrobial drug use practices in companion animals and the potential impacts ...

Workshop on Generic Drug Research Initiatives

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Federal Register notice: FDA announces a 5/9-10 public workshop entitled FY 2022 Generic Drug Science and Research Initiatives Wor...

FDA Advisors Nix IV Tramadol

[ Price : $8.95]

Members of two FDA advisory committees say Avenue Therapeutics IV Tramadol has risks that exceed benefits.

CBER Covid-19 International Collaboration

[ Price : $8.95]

An online CBER report describes Center collaborative efforts with international partners on Covid-19.