Regulatory Focus™ > News Articles > Regulatory Recon: Impax Hit With FDA 483 for Facility Troubles (29 July 2014)

Regulatory Recon: Impax Hit With FDA 483 for Facility Troubles (29 July 2014)

Posted 29 July 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Impax Hit With FDA 483 for Facility Troubles (29 July 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

  • FDA raises concerns about Impax's Taiwanese plant (Reuters) (PharmPro) (483)
  • Senators Question FDA About Efforts to Curb Antibiotic Overuse in Food Animals (Senate) (Letter) (Law 360-$) (Pharmalot)
  • ANDA Stability Requirements To Be Broadly Grandfathered, FDA Says (Pink Sheet-$)
  • Sandoz biosimilar Neupogen application presents three regulatory challenges for FDA (BioCentury-$)
  • FDA's Biggest New Policies Of 2014: Midyear Report (Law 360-$)
  • FDA OKs Imbruvica in Tough-to-Treat Form of CLL (MedPage Today) (Press) (FDA) (SCRIP-$) (BioCentury)
  • FDA Staff Questions Prostate Cancer Device Effectiveness (Bloomberg)
  • Unapproved changes: Recent FDA warning letters (Medical Device Daily)
  • Adding UDIs To Claims Is Crucial for Device Surveillance, Pew Tells Congress (Gray Sheet-$)

In Focus: International

  • Roche’s Gazyvaro granted European Commission approval for leukemia (Pharma Letter-$) (SCRIP-$) (Reuters) (Press) (Pharmafile)
  • European Commission Approves BMS/Pfizer's Eliquis (apixaban) for DVT and PE (Press)
  • Where are we with the MDR and IVDR after the Greek Presidency? (Medical Devices Legal)
  • Roche "may appeal" after judge backs MHRA in pharmacovigilance case (SCRIP-$)
  • India Wants to Limit Import of APIs from China (PharmaBiz)
  • Australian Health Minister's bid to censor CF comments backfires (PharmaPhorum)
  • Revised Medical Device Definitions Implemented in New Zealand (Emergo)

US: Pharmaceuticals and Biotechnology

  • Senators Question FDA About Efforts to Curb Antibiotic Overuse in Food Animals (Senate) (Letter) (Law 360-$) (Pharmalot)
  • FDA raises concerns about Impax's Taiwanese plant (Reuters) (PharmPro) (483)
  • ANDA Stability Requirements To Be Broadly Grandfathered, FDA Says (Pink Sheet-$)
  • Sandoz biosimilar Neupogen application presents three regulatory challenges for FDA (BioCentury-$)
  • FDA's Biggest New Policies Of 2014: Midyear Report (Law 360-$)
  • FDA OKs Imbruvica in Tough-to-Treat Form of CLL (MedPage Today) (Press) (FDA) (SCRIP-$) (BioCentury)
  • At Least One Company is Promoting its Product on Twitter (Twitter)
  • Ranbaxy Earnings Hit by Regulatory Problems (Bloomberg)
  • NDAC Input Sought On Sunscreen Ingredient Data Necessary For Approval (Tan Sheet-$)
  • A short history of MannKind's long road with Afrezza (BioCentury-$)
  • Moms’ Marijuana-for-Kids Campaign Seeks to Quiet Epilepsy (Bloomberg)
  • Bill Would Exempt "Terapeutic Hemp and Cannabidiol" from CSA (House)
  • FDA Talks Antibiotic Innovation (FDA)
  • FDA Touts New HepC Treatments (FDA)

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

US: Pharmaceuticals and Biotechnology: General

  • Illinois Medicaid restricts who can get 'game-changing' hepatitis drug (Crain's)
  • Mom Tells Troubled Biotech to Stop Squabbling: 'Just Get My Kid the Drug' (Bloomberg)

US: Medical Devices

  • FDA Staff Questions Prostate Cancer Device Effectiveness (Bloomberg)
  • Unapproved changes: Recent FDA warning letters (Medical Device Daily)
  • Adding UDIs To Claims Is Crucial for Device Surveillance, Pew Tells Congress (Gray Sheet-$)
  • In sunny world of LASIK marketers, a dark underbelly (MM&M)
  • Guided Therapeutics finally re-files PMA for cervical scanner (Mass Device)
  • Teleflex Receives FDA Clearance for 150 cm Length Arrow GPSCath Balloon Dilatation Catheters (Press)
  • Philips VISIQ Tablet Ultrasound Now Cleared in U.S. (Mass Device)
  • IRS collected $1.4B in medtech excise tax payments in 2013 (Mass Device)

US: Dietary Supplements

  • Fly-by-night weight loss marketer pays $500,000 to settle FTC claim  (NI-USA)

US: Assorted And Government

  • What About a Private Alternative to the FDA? (National Review)
  • Is Big Pharma Testing Your Meds on Homeless People? How the destitute and the mentally ill are being used as human lab rats (Medium)
  • New Guidelines on Patent Eligibility for Subject Matter Derived from Nature (CATO)
  • Physician Payments Sunshine Act: Medical Groups Petition CMS to Add Proper Context to Payments, Increase Physician Outreach, Simplify Open Payments Registration (Policy and Medicine)

Europe

  • Roche’s Gazyvaro granted European Commission approval for leukemia (Pharma Letter-$) (SCRIP-$) (Reuters) (Press) (Pharmafile)
  • European Commission Approves BMS/Pfizer's Eliquis (apixaban) for DVT and PE (Press)
  • Where are we with the MDR and IVDR after the Greek Presidency? (Medical Devices Legal)
  • Roche "may appeal" after judge backs MHRA in pharmacovigilance case (SCRIP-$)
  • Registry data shows high risk of blood clot among users of Abbott's bioresorbable stent (Fierce)
  • EC approves Veloxis' Envarsus (BioCentury) (Press)
  • pSivida’s Iluvien given marketing authorization in Norway and reimbursement approval in Portugal (Pharma Letter-$)
  • EU Rule Sets Higher Standard For Medical Devices (Law 360-$)
  • IQWiG Endorses New Patient Preference Analysis Standard (IQWiG)
  • Copycat Lipitor helps toward £1.3bn NHS savings (Pharmafile)
  • Generic usage increased to more than 75% in the UK in 2013 according to NHS data (MNT)

India

  • India Wants to Limit Import of APIs from China (PharmaBiz)
  • DCGI sets up Independent Expert Committee on Cardiology for trial deaths caused by drugs (PharmaBiz)

China

  • China sets date for GSK Bribery Trial (FT-$)

Canada

  • Clinical Trial Hurdle for Wider Use of Medical Marijuana in Canada (Ottowa Citizen)

Australia

  • Australian Health Minister's bid to censor CF comments backfires (PharmaPhorum)
  • TGA Issues Warning on J&J's Codman Certas Programmable Valves (TGA)
  • TGA Touts Website Improvements, Better Search Function (TGA)
  • Medicines Australia Code of Conduct: Payment Reporting Starts October 1, 2015 (Policy and Medicine)

Other International

  • Revised Medical Device Definitions Implemented in New Zealand (Emergo)

General Regulatory And Interesting Articles

  • What is Reference Pricing? (Healthcare Economist)
  • Drugs to increase 'good' cholesterol may not cut deaths (Reuters)
  • Dubai pays kids -- in gold -- to lose weight (CBS)

Regulatory Reconnaissance #367 – 29 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.

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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