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Apr 14 2011FDA opts for “effective remedy” with Triad
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Nov 14 2024Apex, NC Plant Receives FDA Warning Letter for cGMP Violations
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Oct 24 2024North Carolina Thermo Fisher Plant Gets 483 For Contamination and Air Bubble Problems
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Oct 10 2024FDA Representative Predicts More Onsite Inspections, Reveals Current Warning Letter Trends
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Sep 6 2024India’s Zydus Hit With FDA Warning Letter
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Aug 29 2024FDA Finalizes cGMP Guidance for ANDA Facilities
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Aug 28 2024EyePoint Receives FDA Warning Letter For cGMP Shortfalls Related To Eye Implant
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Aug 15 2024FDA Sends Warning Letter To Surgical Robot Maker Globus
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Aug 13 2024FDA Sends Warning Letters To Chinese Syringe Manufacturer
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Aug 12 2024FDA Hits Aurobindo With OAI 483
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Aug 1 2024FDA Reams Out Indian CDMO Brassica for Falsifying Data and Bad Hygiene
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Jul 29 2024Most Common FDA 483 Violations in 2023
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Jul 13 2024FDA Blasts Kilitch For Dirty Manufacturing Conditions
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Jul 13 2024Two Dr. Reddy’s Plants Hit With 483s in India
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Jul 7 2024FDA Making Life Difficult For Indian Pharma Companies
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Jun 23 2024FDA Sears China’s Hengrui In Recent 483
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Jun 19 2024FDA Gets Into The Weeds On HCT/P Rules In Warning Letter To Human Tissue Firm
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Jun 18 2024Why FDA Will Have Difficulty Regulating Marijuana
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Jun 18 2024Zentalis Shares Drop 30% After FDA Puts Partial Hold on WEE1 Drug
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Jun 2 2024FDA Blasts Laurus Synthesis With Untitled Letter
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May 17 2024FDA Warning Letter Delivered to Cue Health in May 2024
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May 15 2024Companies Aren’t Required To Respond To FDA 483s
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May 15 2024Eugia Hit With Another 483 in Less Than a Year
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Jul 18 2022Dr. Reddy’s Laboratories Slapped With 483 After FDA Preapproval Inspection
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Jul 18 2022FDA Commissioner Wants To Revamp The Evidence Generation System
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Jul 17 2022FDA User Fee Bill Deadline Passes; FDA Reviewers May Be Laid Off
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Jul 14 2022EMA Planning Transition To Reviewing Raw Clinical Data
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Jul 12 2022Texas Pharmaceutical Company Hit With 483 For Missing Records and Inadequate Processes
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Jul 11 2022Congress Urges FDA To Adopt Clearer, Neutral Rules For Pharmaceutical Drug Ads
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Jul 5 2022FDA Notes cGMP Failures In Warning Letter For 503B Compound Outsourcing Facility
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Jul 3 2022Aurobindo Pharma Hit With Warning Letter From Indian SEC After More FDA Questions
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Jul 1 2022FDA Hits US API Facility With Warning Letter When Workers Destroy Cleaning Logs
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Jun 21 2022FDA Gives 483 To Spanish Drug Ingredient Maker Bioberica
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Jun 17 2022FDA Approves New Cancer Drugs Faster Than EMA
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Jun 16 2022FDA Oversight Of Drug Manufacturing Facilities Plunged During Pandemic
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Jun 8 2022How The US And FDA Can Reduce Medical Device Shortages
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Jun 5 2022Italian Antitrust Regulators Fine Pharma Company For ‘Excessive Pricing’ of Disease Drug
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Jun 3 2022FDA Documents Reveal cGMP Issues At Novartis Plant Where Cancer Drug Production Was Stopped
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Jun 2 2022FDA Needs To Do More To Prevent Food Shortages
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May 20 2022National Academies Stresses ‘Urgent’ Need to Recruit More Diverse Patients For Clinical Trials
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May 19 2022Congress Slowly Reforming FDA Accelerated Approvals, But With Pharma-Friendly Regulations
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May 18 2022FDA Sends Warning Letter To Miami University Contract Testing Laboratory For Poor QC And Faked Data
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May 17 2022Brigham and Women’s Receives FDA Warning Letter After PET Operation Flaws
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May 16 2022Generic Drug Manufacturer Slapped With FDA 483
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May 15 2022US House Conducting User Fee Markup
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May 14 2022Will FDA Update How It Approves Drugs After Alzheimer’s Mess?
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May 12 2022FDA User Fee Reauthorizations Supported By Both Sides Of The Aisle On Capitol Hill
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May 10 2022How to Survive Your Next FDA Inspection – June 15, 2022, 2 PM EDT
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May 3 2022FDA Turns Down China-Produced Cancer Drug
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May 2 2022FDA Rejects Axsome Migraine Medication, But Problems Are Addressable
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Apr 27 2022FDA Sends PI Warning Letter For Not Checking Trial Participants’ Eligibility
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Apr 25 2022FDA Warning Clinical Trial Companies For Not Reporting Trial Results
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Apr 22 2022GAO Says FDAers Experienced Political Interference In Scientific Decisions During Trump Era
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Apr 21 2022FDA Rejects Teva and MedinCell’s Schizophrenia Drug Application
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Apr 19 2022Indian API Plant Receives FDA 483
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Apr 18 2022Questions Remain After FDA Offers New Designation To Medical Device Manufacturers
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Apr 15 2022FDA Appears To Be Tightening Regulations For Drug Approvals
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Apr 14 20222 US Drug Manufacturers Get FDA Warning Letter For Poor Investigations, Lax Testing and Validation
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Apr 13 2022FDA Issues Device Cybersecurity Draft Guidance
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Apr 13 2022How to Handle An FDA Warning Letter
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Apr 8 2022FDA Talks About Importance of Data Integrity And Data Governance Plans
