-
Apr 14 2011FDA opts for “effective remedy” with Triad
-
Jul 13 2024FDA Blasts Kilitch For Dirty Manufacturing Conditions
-
Jul 13 2024Two Dr. Reddy’s Plants Hit With 483s in India
-
Jul 7 2024FDA Making Life Difficult For Indian Pharma Companies
-
Jun 23 2024FDA Sears China’s Hengrui In Recent 483
-
Jun 19 2024FDA Gets Into The Weeds On HCT/P Rules In Warning Letter To Human Tissue Firm
-
Jun 18 2024Why FDA Will Have Difficulty Regulating Marijuana
-
Jun 18 2024Zentalis Shares Drop 30% After FDA Puts Partial Hold on WEE1 Drug
-
Jun 2 2024FDA Blasts Laurus Synthesis With Untitled Letter
-
May 17 2024FDA Warning Letter Delivered to Cue Health in May 2024
-
May 15 2024Companies Aren’t Required To Respond To FDA 483s
-
May 15 2024Eugia Hit With Another 483 in Less Than a Year
-
Jul 18 2022Dr. Reddy’s Laboratories Slapped With 483 After FDA Preapproval Inspection
-
Jul 18 2022FDA Commissioner Wants To Revamp The Evidence Generation System
-
Jul 17 2022FDA User Fee Bill Deadline Passes; FDA Reviewers May Be Laid Off
-
Jul 14 2022EMA Planning Transition To Reviewing Raw Clinical Data
-
Jul 12 2022Texas Pharmaceutical Company Hit With 483 For Missing Records and Inadequate Processes
-
Jul 11 2022Congress Urges FDA To Adopt Clearer, Neutral Rules For Pharmaceutical Drug Ads
-
Jul 5 2022FDA Notes cGMP Failures In Warning Letter For 503B Compound Outsourcing Facility
-
Jul 3 2022Aurobindo Pharma Hit With Warning Letter From Indian SEC After More FDA Questions
-
Jul 1 2022FDA Hits US API Facility With Warning Letter When Workers Destroy Cleaning Logs
-
Jun 21 2022FDA Gives 483 To Spanish Drug Ingredient Maker Bioberica
-
Jun 17 2022FDA Approves New Cancer Drugs Faster Than EMA
-
Jun 16 2022FDA Oversight Of Drug Manufacturing Facilities Plunged During Pandemic
-
Jun 8 2022How The US And FDA Can Reduce Medical Device Shortages
-
Jun 5 2022Italian Antitrust Regulators Fine Pharma Company For ‘Excessive Pricing’ of Disease Drug
-
Jun 3 2022FDA Documents Reveal cGMP Issues At Novartis Plant Where Cancer Drug Production Was Stopped
-
Jun 2 2022FDA Needs To Do More To Prevent Food Shortages
-
May 20 2022National Academies Stresses ‘Urgent’ Need to Recruit More Diverse Patients For Clinical Trials
-
May 19 2022Congress Slowly Reforming FDA Accelerated Approvals, But With Pharma-Friendly Regulations
-
May 18 2022FDA Sends Warning Letter To Miami University Contract Testing Laboratory For Poor QC And Faked Data
-
May 17 2022Brigham and Women’s Receives FDA Warning Letter After PET Operation Flaws
-
May 16 2022Generic Drug Manufacturer Slapped With FDA 483
-
May 15 2022US House Conducting User Fee Markup
-
May 14 2022Will FDA Update How It Approves Drugs After Alzheimer’s Mess?
-
May 12 2022FDA User Fee Reauthorizations Supported By Both Sides Of The Aisle On Capitol Hill
-
May 10 2022How to Survive Your Next FDA Inspection – June 15, 2022, 2 PM EDT
-
May 3 2022FDA Turns Down China-Produced Cancer Drug
-
May 2 2022FDA Rejects Axsome Migraine Medication, But Problems Are Addressable
-
Apr 27 2022FDA Sends PI Warning Letter For Not Checking Trial Participants’ Eligibility
-
Apr 25 2022FDA Warning Clinical Trial Companies For Not Reporting Trial Results
-
Apr 22 2022GAO Says FDAers Experienced Political Interference In Scientific Decisions During Trump Era
-
Apr 21 2022FDA Rejects Teva and MedinCell’s Schizophrenia Drug Application
-
Apr 19 2022Indian API Plant Receives FDA 483
-
Apr 18 2022Questions Remain After FDA Offers New Designation To Medical Device Manufacturers
-
Apr 15 2022FDA Appears To Be Tightening Regulations For Drug Approvals
-
Apr 14 20222 US Drug Manufacturers Get FDA Warning Letter For Poor Investigations, Lax Testing and Validation
-
Apr 13 2022FDA Issues Device Cybersecurity Draft Guidance
-
Apr 13 2022How to Handle An FDA Warning Letter
-
Apr 8 2022FDA Talks About Importance of Data Integrity And Data Governance Plans
-
Apr 7 2022FDA Issues Warning Letter To Stem Cell Company For cGMP Violations
-
Apr 6 2022Cadila Healthcare Hit With 483 After Rare International FDA Inspection
-
Apr 3 2022FDA Stresses The Importance Of Engaging With The Agency Early and Formally
-
Apr 1 2022What’s Going On With FDA and Computer Software Assurance (CSA)?
-
Mar 30 2022Is Your cGMP Quality System Ready For An FDA Inspection?
-
Mar 29 2022GAO Recommends Overhauling FDA Foreign Inspection Program
-
Mar 28 2022FDA Resumes Foreign Inspections Amid Quality Concerns
-
Mar 27 2022Lonza Increases HPAPI Manufacturing With New cGMP Facility In China
-
Mar 27 2022Most Common FDA 483 Inspection Observations in 2020
-
Mar 26 2022FDA Proposes Rule To Change Device cGMP Requirements
-
Mar 25 2022What FDA Guidance Documents Can Drugmakers Expect in 2022?
