Regulatory Focus™ > News Articles > Regulatory Recon: The Most Common GMP Violations in FDA Warning Letters Are… (16 July 2014)

Regulatory Recon: The Most Common GMP Violations in FDA Warning Letters Are… (16 July 2014)

Posted 16 July 2014 | By Alexander Gaffney, RAC

Regulatory Recon: The Most Common GMP Violations in FDA Warning Letters Are… (16 July 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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In Focus: US

  • Analysis: The most common GMP violations in the FDA warning letters (ECA)
  • FDA: Impact of Pediatric Exclusivity on Drug Labeling and Demonstrations of Efficacy (PubMed)
  • US Falls Behind in Facilitating New Antibiotics Pipeline (PharmTech)
  • Cardio Triple-Combo Drugs To Get FDA Panel Review (Pink Sheet-$) (FDA) (BioCentury)
  • In NJEM, Debate Over Usefulness of Breakthrough Product Designation (NEJM)
  • FDA Rejects Ban On Controversial Vaginal Mesh Products (Law 360-$)
  • Premarket Approval Supplement Pathway: Do We Know What We Are Getting? (AIM)
  • How Should an FDA Audit of a Facility Unfold? (Gray Sheet-$)

In Focus: International

  • Governments agree to rein in veterinary drugs in food (AFP)
  • The EMA’s scientific advice to pharma companies is a conflict of interest, says industry coalition (Pharma Letter-$)
  • Health Canada Flags Concerns About Testosterone Products, Calls for Labeling Changes (HC) (CBC)
  • 3 Key Facts From The EU's Latest Pay-For-Delay Case (Law 360-$)
  • WHO praises China vaccine rules and flags country as future supply hub (BioPharma Reporter)

US: Pharmaceuticals and Biotechnology

  • Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters (ECA)
  • FDA: Impact of Pediatric Exclusivity on Drug Labeling and Demonstrations of Efficacy (PubMed)
  • US Falls Behind in Facilitating New Antibiotics Pipeline (PharmTech)
  • Cardio Triple-Combo Drugs To Get FDA Panel Review (Pink Sheet-$) (FDA) (BioCentury)
  • FDA Holding Meeting on Pediatric Drug Development (FDA) (BioCentury)
  • Congressional Meeting Scheduled on Communication—Could Relaxation of Marketing Restritions be on the Menu? (E&C)
  • In social media, what's easier to grasp, an FDA webinar or an FDA warning letter?(Fierce)
  • Former FDA Associate Commissioner Takes Aim at Compounded Animal Drugs (DrugWonks)
  • CDC, FDA Researchers Say HepA, HepB Vaccines Safe for Pregnant Women (PubMed)
  • In NJEM, Debate Over Usefulness of Breakthrough Product Designation (NEJM)
  • Missouri Signs "Right-to-Try" Legislation Into Law (MissouriNet)
  • Industry Seeks Clearer Track-and-Trace Standards (PharmExec)
  • Want to Unlock the 21st Century Cure? Hearing Witnesses Agree, Patient Input is Key (FDA Law Blog)
  • Merck prods cattle producers to help it test the safety of withdrawn Zilmax (Fierce)
  • Purdue Pharma L.P. Receives FDA Approval for 7.5 mcg/hour Dosage Strength of Butrans (Buprenorphine) Transdermal System CIII (Press)
  • Octapharma USA Announces FDA Approval of Octagam 10% (Press)
  • Actavis Sued Over Generic Morning Sickness Drug (Law 360-$)
  • Mutual Pharma Inks $9M Deal To Settle Pay-For-Delay Claims (Law 360-$)
  • Iowa Court Offers Limited Boost To Generic-Drug Injury Suits (Law 360-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • POZEN Announces FDA Acceptance of Refiling of New Drug Application for PA8140/PA32540 Tablets (Press)
  • FDA Designates AntiOp Opioid Overdose Treatment for Fast Track Development Program (PharmPro)
  • Pfizer Announces Positive Top-Line Results From Phase 3 Study Of NONACOG ALFA (BeneFIX®) Once-Weekly Prophylaxis For Hemophilia B (Press)
  • Concert Pharmaceuticals Announces FDA Lifts Partial Clinical Hold for CTP-354, A Novel Drug Candidate for Spasticity (Press)

US: Pharmaceuticals and Biotechnology: General

  • National Coalition On Health Care Spearheads Rx-Price Sunshine Push; PhRMA Resists (IHP-$)
  • The Genetics Revolution Challenge and How to Incentivize Biomedical Research Using Prizes (AEI)
  • Rising heart drug price pulls Impax into Connecticut AG investigation (BizJournal) (Reuters)
  • Poll: 4 in 5 say $1,000-a-pill drug cost ‘unacceptable’ (The Hill)

US: Medical Devices

  • FDA Rejects Ban On Controversial Vaginal Mesh Products (Law 360-$)
  • Premarket Approval Supplement Pathway: Do We Know What We Are Getting? (AIM)
  • How Should an FDA Audit of a Facility Unfold? (Gray Sheet-$)
  • Why Aren't There Any FDA-Approved Lyme Disease Tests? (NECIR)
  • May 2014 PMA Approvals (FDA)

US: Dietary Supplements

  • TriVita Settles with FTC on Cactus Fruit Drink Health Claims (NPI)

US: Assorted And Government

  • Donating a kidney may make it difficult to change or initiate life and health insurance (Press)

Europe

  • The EMA’s scientific advice to pharma companies is a conflict of interest, says industry coalition (Pharma Letter-$)
  • 3 Key Facts From The EU's Latest Pay-For-Delay Case (Law 360-$)
  • French studies show oral anticoagulants do not cause an increased risk of severe hemorrhage despite recent deaths (Pharma Letter-$)

India

  • Industry wants Centre to adopt steps to rectify regulatory hurdles on medical devices to help domestic units (PharmaBiz)

China

  • WHO praises China vaccine rules and flags country as future supply hub (BioPharma Reporter)

Canada

  • Health Canada Flags Concerns About Testosterone Products, Calls for Labeling Changes (HC) (CBC)
  • Health Canada’s Approval of IBAVYR Enables Specific Patients with Chronic Hepatitis C Infection to Be Treated with an All-Oral Regimen (Press)

Australia

  • Concern over unproven stem cell therapies in Australia (PHG)

Other International

  • Governments agree to rein in veterinary drugs in food (AFP)
  • Nine children fed with Teva intravenous solution, suffer blood infection (yNet)

Clinical Trials

  • How Frequently Do the Results from Completed US Clinical Trials Enter the Public Domain? - A Statistical Analysis of the ClinicalTrials.gov Database (PLoS One) (AllTrials)

General Regulatory And Interesting Articles

  • Creating Sustainable Compliance Frameworks: Embedding Regulatory Compliance within Optimized Business Processes (PCM)
  • Endocrinologists least likely doctors to prescribe biosimilars (BioPharma Reporter)
  • New assay to spot fake malaria drugs could save thousands of lives (Press)

Regulatory Reconnaissance #358 – 16 July 2014

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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