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Durbin Bills Would Provide Research Funding Increases

Sen. Richard Durbin, joined by other Democrats, introduces legislation to provide annual funding increases for biomedical and scientific research at s...

Human Drugs

Alkermes Starts MS Drug Phase 3 Test

Alkermes opens multiple sclerosis drug Phase 3 trial aiming for a 2018 NDA submission.

Human Drugs

Asana Bio Proposes ASN002 Study in Atopic Dermatitis

FDA accepts an Asana BioSciences IND for ASN002, a novel dual SYK-JAK inhibitor, for treating atopic dermatitis.

GAO Still Finds Gaps in Food Animal Antibiotic Use Data

The Government Accountability Office says that FDA and the Agriculture Department need to do more work to provide oversight of medically important ant...

Human Drugs

Panel Says Opanas Risks Outweigh Benefits

FDAs Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees votes 18 to 8 that that the benefits of reformulat...

Federal Register

Comments Extended on Biosimilar Interchangeability Guidance

Federal Register Notice: FDA extends the comment period for a 1/18 notice regarding a guidance on Considerations in Demonstrating Interchangeability w...

Federal Register

FDA Posts 10 OMB Comment Request Notices

FDA posts ten Office of Management and Budget information collection notices that have been backlogged and now released after a regulatory review by t...

Federal Register

Glucose Monitor Display Put Into Class 2

Federal Register Final Order: FDA classifies as a Class 2 (special controls) medical device the continuous glucose monitor secondary display.

Federal Register

Genomic Sequence Analyzer Put Into Class 2

Federal Register Final Order: FDA classifies as a Class 2 (special controls) medical device the high throughput genomic sequence analyzer for clinical...

Federal Register

Vibratory Counter-Stimulator Put Into Class 2

Federal Register Final Order: FDA classifies as a Class 2 (special controls) medical device the vibratory counter-stimulation device.