test

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