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Guide on Atopic Dermatitis Pediatric Studies

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance entitled Atopic Dermatitis: Timing of Pediatric Studies During Development...

Fast Track for VistaGen Non-opioid Pain Killer

[ Price : $8.95]

FDA grants VistaGen Therapeutics a fast track designation for AV-101, a non-opioid, non-sedating treatment for neuropathic pain.

QS, MDR Violations at Datascope

[ Price : $8.95]

FDA warns Datascope Corp. about Quality System and Medical Device Reporting violations in its manufacturing of several medical dev...

FDA Revises 505(q) Petition Guidance

[ Price : $8.95]

FDA commissioner Scott Gottlieb says a revised draft guidance should improve the predictability and efficiency of generic drug rev...

Panel to Hear DNA Virus Lab Research

[ Price : $8.95]

Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to hear an over...

Lilly Plans 2019 NDA for Diabetes Therapy URLi

[ Price : $8.95]

Eli Lilly plans to submit an NDA for Ultra Rapid Lispro in 2019 after reporting favorable clinical trial data from two Phase 3 tri...

Special 510(k) Program Draft Guidance

[ Price : $8.95]

Federal Register notice: FDA issues a draft guidance entitled The Special 510(k) Program.

FDA Debars Richard Fleming Due to Fraud Probe

[ Price : $8.95]

Federal Register notice: FDA issues an order to debar Richard M. Fleming for 10 years from providing services in any capacity to a...

PET Drug CGMP Violations at N-Molecular

[ Price : $8.95]

FDA warns N-Molecular about CGMP violations in its production of PET drugs.