test

Apr 14 2011
FDA opts for “effective remedy” with Triad
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FDA Issues Device Cybersecurity Draft Guidance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
Apr 10 2019
You Canâ€™t Change That: FDA Reiterates Risk of Delegating Responsibility in Quality Agreements
Apr 10 2019
You Canâ€™t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter
Apr 10 2019
Anyone Can Enter Into a Quality Agreement, It’s the Hold: FDA Issues a Warning Letter Referencing Lack of Quality Oversight
Apr 6 2019
FDA Essential: A Strong cGMP Quality Agreement| June 24, 2019, MINSK
Mar 22 2019
FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy | June 6, 2019, 2 PM EDT | Hoffman
Oct 23 2018
Federal Judge Issues Consent Decree for OTC Tennessee Drug Manufacturer
Oct 23 2018
Catalent Fixes 483 Citations at Bloomington, Indiana Plant
Oct 23 2018
FDA Corrects Import Ban for Embattled Valsartan Maker
Oct 23 2018
FDA Doubts McKesson’s Abilities to Detect Illegitimate Drug Products
Oct 11 2018
How to Fail an FDA Medical Device Inspection in 3 Easy Steps!
Oct 2 2018
What You Should Expect in GMP Quality Agreements
Oct 2 2018
Don’t Be Haunted By Your Words in Documents
Oct 1 2018
DEA Moves Cannibidiol to Schedule V of the Controlled Substances Act
Oct 1 2018
Tips for Implementing a Root Cause Failure Analysis Program
Sep 29 2018
FDA Approval of Cannabis-Based Drug Will Lead to More Medications
Sep 28 2018
Top 10 Reasons Deviation Investigation Systems Fail
Sep 27 2018
Estabilishing a Legal Cannabis Business – What To Know
Sep 26 2018
Using Root Cause Analysis to Find Pharmaceutical Manufacturing Deviations