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Apr 14 2011
FDA opts for “effective remedy” with Triad
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Jul 18 2022
Dr. Reddy’s Laboratories Slapped With 483 After FDA Preapproval Inspection
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Jul 18 2022
FDA Commissioner Wants To Revamp The Evidence Generation System
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Jul 17 2022
FDA User Fee Bill Deadline Passes; FDA Reviewers May Be Laid Off
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Jul 14 2022
EMA Planning Transition To Reviewing Raw Clinical Data
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Jul 12 2022
Texas Pharmaceutical Company Hit With 483 For Missing Records and Inadequate Processes
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Jul 11 2022
Congress Urges FDA To Adopt Clearer, Neutral Rules For Pharmaceutical Drug Ads
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Jul 5 2022
FDA Notes cGMP Failures In Warning Letter For 503B Compound Outsourcing Facility
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Jul 3 2022
Aurobindo Pharma Hit With Warning Letter From Indian SEC After More FDA Questions
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Jul 1 2022
FDA Hits US API Facility With Warning Letter When Workers Destroy Cleaning Logs
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Jun 21 2022
FDA Gives 483 To Spanish Drug Ingredient Maker Bioberica
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Jun 17 2022
FDA Approves New Cancer Drugs Faster Than EMA
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Jun 16 2022
FDA Oversight Of Drug Manufacturing Facilities Plunged During Pandemic
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Jun 8 2022
How The US And FDA Can Reduce Medical Device Shortages
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Jun 5 2022
Italian Antitrust Regulators Fine Pharma Company For ‘Excessive Pricing’ of Disease Drug
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Jun 3 2022
FDA Documents Reveal cGMP Issues At Novartis Plant Where Cancer Drug Production Was Stopped
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Jun 2 2022
FDA Needs To Do More To Prevent Food Shortages
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May 20 2022
National Academies Stresses ‘Urgent’ Need to Recruit More Diverse Patients For Clinical Trials
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May 19 2022
Congress Slowly Reforming FDA Accelerated Approvals, But With Pharma-Friendly Regulations
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May 18 2022
FDA Sends Warning Letter To Miami University Contract Testing Laboratory For Poor QC And Faked Data
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May 17 2022
Brigham and Women’s Receives FDA Warning Letter After PET Operation Flaws
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May 16 2022
Generic Drug Manufacturer Slapped With FDA 483
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May 15 2022
US House Conducting User Fee Markup
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May 14 2022
Will FDA Update How It Approves Drugs After Alzheimer’s Mess?
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May 12 2022
FDA User Fee Reauthorizations Supported By Both Sides Of The Aisle On Capitol Hill
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May 10 2022
How to Survive Your Next FDA Inspection – June 15, 2022, 2 PM EDT
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May 3 2022
FDA Turns Down China-Produced Cancer Drug
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May 2 2022
FDA Rejects Axsome Migraine Medication, But Problems Are Addressable
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Apr 27 2022
FDA Sends PI Warning Letter For Not Checking Trial Participants’ Eligibility
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Apr 25 2022
FDA Warning Clinical Trial Companies For Not Reporting Trial Results
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Apr 22 2022
GAO Says FDAers Experienced Political Interference In Scientific Decisions During Trump Era
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Apr 21 2022
FDA Rejects Teva and MedinCell’s Schizophrenia Drug Application
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Apr 19 2022
Indian API Plant Receives FDA 483
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Apr 18 2022
Questions Remain After FDA Offers New Designation To Medical Device Manufacturers
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Apr 15 2022
FDA Appears To Be Tightening Regulations For Drug Approvals
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Apr 14 2022
2 US Drug Manufacturers Get FDA Warning Letter For Poor Investigations, Lax Testing and Validation
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Apr 13 2022
FDA Issues Device Cybersecurity Draft Guidance
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Apr 13 2022
How to Handle An FDA Warning Letter
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Apr 8 2022
FDA Talks About Importance of Data Integrity And Data Governance Plans
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Apr 7 2022
FDA Issues Warning Letter To Stem Cell Company For cGMP Violations
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Apr 6 2022
Cadila Healthcare Hit With 483 After Rare International FDA Inspection
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Apr 3 2022
FDA Stresses The Importance Of Engaging With The Agency Early and Formally
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Apr 1 2022
What’s Going On With FDA and Computer Software Assurance (CSA)?
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Mar 30 2022
Is Your cGMP Quality System Ready For An FDA Inspection?
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Mar 29 2022
GAO Recommends Overhauling FDA Foreign Inspection Program
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Mar 28 2022
FDA Resumes Foreign Inspections Amid Quality Concerns
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Mar 27 2022
Lonza Increases HPAPI Manufacturing With New cGMP Facility In China
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Mar 27 2022
Most Common FDA 483 Inspection Observations in 2020
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Mar 26 2022
FDA Proposes Rule To Change Device cGMP Requirements
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Mar 25 2022
What FDA Guidance Documents Can Drugmakers Expect in 2022?
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Mar 24 2022
Shared Qualification Audits Are Best Practice For Phase 1 Drugs
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Mar 23 2022
How To Avoid FDA 483 in 2022 and Beyond!
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Mar 20 2022
GotoWebinar: CGMP’s DHF, DMR, DHR, and EU’s Technical Documentation – May 17, 2022, 1 PM EDT – Lincoln
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Mar 20 2022
Damage Control! How to Handle an FDA Drug or Device Recall – June 12, 2 PM EDT – Moore
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Mar 18 2022
How To Survive Your Next FDA Inspection – Survival Guide Tips and Techniques, May 19, 2022, 2 PM EST | Moore
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Mar 14 2022
How Pharmaceutical Packaging Can Lead to Product Recalls
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Mar 11 2022
Why Do You Need a Quality Agreement?
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Apr 22 2019
GotoWebinar: Verification and Validation Planning and Execution – July 24, 1 PM EDT – Lincoln
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Apr 22 2019
GotoWebinar: Bullet-Proof Closed-Loop CAPA, Failure Investigation, and Root Cause Analysis – June 5 – Lincoln
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Apr 12 2019
Canada Has Completed Its Transition to MDSAP
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Apr 12 2019
FDA Audit Shows Data Manipulation at Immunonedics Plant