FDA to Help With Legislation to Curb Generic Drug Delays 09/22/2016

Look at FDA Enforcement and 1st Amendment: MIWG 09/22/2016

Rep. Fitzpatrick Seeks Hearing on FDA and Device Safety 09/23/2016

House Committee Leaders Want OCI Update 09/21/2016

CDRH Sets 10 Regulatory Science Priorities 09/20/2016

FDA Policy Makes Journalist ‘Watchdogs into Lapdogs’: Analysis 09/22/2016

Diabetes Drugs Riskiest to Develop: Tufts Study 09/20/2016

False Advertising Claim Not Precluded by FFDCA 09/21/2016

Groups Fear Weakened REMS 09/21/2016

Computational Modeling Studies Reporting Guidance 09/20/2016

Sherman Moves Into Califf’s Former Position 09/26/2016

Since Our Last Issue ... 09/25/2016

Latest Federal Register Notices 09/25/2016

Product Approval Summaries 09/25/2016

CGMP Violations in Hebei Yuxing Inspection 09/22/2016

Generic Drug Facility Self-Identification Guidance 09/22/2016

Pediatric Voucher Program Expires October 1 09/22/2016

Office of Clinical Pharmacology Good Review Practices 09/22/2016

FDA Lab Test Proposal is ‘Double Regulation’: Senator 09/21/2016

CDER Office of Surveillance and Epidemiology MAPP 09/21/2016

Adverse Events Unreported in Published Studies: Research 09/21/2016

‘Roundabout’ Causation in Failure-to-Report Claims: Attorney 09/20/2016

Alcon Wants Durezol Bioequivalence Requirements 09/20/2016

Latest FDA Warning Letters 09/20/2016

FDA Draft Guide on Determining When REMS is Necessary 09/20/2016

FDA Rescinds Teva SPA After Dosing Changed 09/19/2016