Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Says Foreign Generics are Safe (26 March 2014)

Regulatory Reconnaissance: FDA Says Foreign Generics are Safe (26 March 2014)

Posted 26 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

In Focus: International

  • GSK pulls melanoma combo file in Europe (Pharma Times) (GSK) (PMLive)
  • EU approval for Cometriq in medullary thyroid carcinoma (Pharma letter-$) (SCRIP-$) (BioCentury)
  • Adaptive Licensing: The Start of a Slow Revolution in Europe (PharmExec)
  • India to Limit Number of Trials a Single Investigator Can Oversee at One Time (PharmaBiz)
  • China Cracks Down On Device Clinical Data Forgery, Problematic Manufacturing (Gray Sheet-$)

US: Pharmaceuticals/Biotechnology

  • Disputing Study, U.S. FDA Says Generics From Abroad Safe (Bloomberg)
  • India generic drugmakers' woes put new focus on quality over price (Reuters)
  • FDA Staff Recommends Rejection of Novartis Heart-Failure Drug (WSJ-$) (BioCentury) (SCRIP-$) (PMLive) (Pharmafile) (Fierce) (Forbes) (Pink Sheet-$) (Pharma Times) (Bloomberg)
  • Is a New Law Trying to Extent the Patent Life of Botox? (FDA Law Blog)
  • "No End In Sight" For Completing OTC Monographs - CDER Director Woodcock (Tan Sheet-$)
  • Limitations Imposed on Use of FDA Warning Letters (FDA Law Blog)
  • Pharma and the First Amendment: A Proposal From the FDA (WSJ)
  • Petition for FDA to Approve DMD Drug Reaches 100K Threshold (ABC)
  • A High Stakes Battle Over Testosterone (WSJ)
  • Patient Whose Case Prompted FDA Action During Shutdown Dies (BioFlash)
  • CHPA on the OTC Monograph System (CHPA)
  • Indiana Signs Biosimilar Substitution Bill into Law (Press)
  • 'Dallas Buyers Club' trial drug measure clears Colorado committee (Fox)
  • Actavis and Valeant Announce FDA Approval for Metronidazole 1.3% (Press)
  • A skewed view on drug shortages (USA Today)
  • Drug Maker Blames 'Misinformation' for Zohydro Controversy (National Pain Report)

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

  • Avanir Pharmaceuticals Announces Acceptance of New Drug Application for AVP-825 for the Acute Treatment of Migraine (Press)
  • Pfizer Achieves Primary Endpoint With Phase 3B Top-Line Results Of GENOTROPIN In Very Young Children Born Small For Gestational Age (Press) (WSJ)

US: Pharmaceuticals and Biotechnology: General

  • Nitroglycerin, a Staple of Emergency Rooms, Is in Short Supply (NYTimes)
  • PhRMA President Castellani Hits Back on Price of HepC Drug Sovaldi (NYTimes)
  • PhRMA Slams FTC's Rationale For Targeting Drugmakers (Law 360-$)

US: Medical Devices

  • FDA Staff Doubts Colon Cancer Blood Test (Medpage Today)
  • FDA and LDTs-What's Next? (GEN)
  • Combination Products 101: A Primer For Medical Device Makers (MedDeviceOnline)
  • FDA Meeting to Discuss Safety, Effectiveness of Aversive Conditioning Devices (FDA)
  • Extensive Warning Letter to Ultradent Products (FDA)
  • St. Jude Approvals Mark Progress With Warning Letter (Gray Sheet-$)
  • Shareholders sue Intuitive Surgical over adverse events, recalls (Mass Device)
  • Israel's Medigus lands FDA win for new MUSE acid reflux treatment (Mass Device) (MedGadget)
  • FDA Approves Optiguide DCYL700 Fiber Optic Diffuser Series flexible fiber (Press)

US: Dietary Supplements

  • Supplement Recalled Due to Undeclared Drug Ingredients (FDA)

US: Assorted And Government

  • The Prolific Pragmatist: Judge Richard Posner (Law 360-$)
  • PCORI Appoints First Members of New Advisory Panel on Rare Disease (PCORI)
  • PCORI Announces Inaugural Members of Advisory Panel on Clinical Trials (PCORI)
  • FDA Calls for Consumer Reps for its Advisory Committees (FDA)



  • India to Limit Number of Trials a Single Investigator Can Oversee at One Time (PharmaBiz)
  • India To Give PR Credits To Drug Makers Who Donate Treatments To Poor (PharmAsia-$)

Japan & China

  • China Cracks Down On Device Clinical Data Forgery, Problematic Manufacturing (Gray Sheet-$)
  • Sandoz receives biosimilar filgrastim approval in Japan (Press)

Other International

  • External reference pricing goes global (SCRIP-$)
  • MedTech Market Access Hurdles are a Global Problem (MDDI)
  • TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2013 (TGA)

General Regulatory And Interesting Articles

  • Once Seen As Too Scary, Editing People's Genes With Viruses Makes A $618 Million Comeback (Forbes)
  • A New Way to Study Hepatotoxicity (In the Pipeline)
  • Ebola Victims Face 90% Death Risk; Drugs Start to Emerge (Bloomberg)
  • Doctors, drugs slowly coming around to chronic fatigue (SF Chronicle)

Regulatory Reconnaissance #284 - 26 March 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.

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