Regulatory Focus™ > News Articles > Regulatory Recon: FDA in Game of Cat and Mouse With Criminal Supplement Maker (8 April 2015)

Regulatory Recon: FDA in Game of Cat and Mouse With Criminal Supplement Maker (8 April 2015)

Posted 08 April 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA in Game of Cat and Mouse With Criminal Supplement Maker (8 April 2015)

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

In Focus: US

  • Controversial sports supplement's return sparks outrage (USA Today)
  • Manchin targets prescription drug ‘epidemic’ (WV Gazette)
  • The Emerging 505(b)(2) Marketplace Provides Opportunities for Generics Companies Seeking New Revenue Streams in the U.S. (Camargo)
  • Approval Withdrawn for Antifreeze Antidote for Dogs (FDA)
  • Fake Avastin incident 'could happen again' (Securing Industry)
  • FDA approach to medical device security is a step backward (GovHealthIT)
  • FDA says ReShape Medical can skip advisory panel for obesity balloon device (Mass Device)
  • FDA open-data platform gains traction (MM&M)

In Focus: International

  • Europe’s Revised Biosimilars Guideline Allows Non-EU Data In Applications (Pink Sheet-$)
  • Mandatory use of eCTD for decentralised procedures (MHRA)
  • Avastin approved for cervical cancer in EU (PMLive) (Press)
  • Pharmacopoeial Harmonization: Focus on Japan (USP)
  • Throwing light on China's clinical trial requirement (Clinica-$)

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US: Pharmaceuticals and Biotechnology

  • Manchin targets prescription drug ‘epidemic’ (WV Gazette)
  • The Emerging 505(b)(2) Marketplace Provides Opportunities for Generics Companies Seeking New Revenue Streams in the U.S. (Camargo)
  • Approval Withdrawn for Antifreeze Antidote for Dogs (FDA)
  • Fake Avastin incident 'could happen again' (Securing Industry)
  • Webinar - Risk Evaluation and Mitigation Strategies: Modifications and Revisions (FDA)
  • How to Make DTC Ad 'Warnings' More Effective (MM&M)
  • Sandoz Agrees Not To Launch First U.S. Biosimilar Until May (IHP-$)
  • Biosimilar Approvals Prompt Drug Swap Difficulties (Medscape)
  • GMPs for Excipient Makers Move Forward (FDAnews-$)
  • Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday? (RxTrace)
  • Analysis of side-effect reports turns up troubling safety signals for Novartis, Eisai drugs (Fierce)
  • Baxter recalls more than half a million units of saline (Fierce)
  • Elepsia XR Approved for Adjunct Seizure Therapy (MPR)

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

  • FDA accepts Novo Nordisk's resubmitted application for insulin drug Tresiba (Reuters) (PharmaTimes) (BioCentury)
  • Gilead's low-dose, high-impact HIV drug heads to the FDA (BizJournal) (Press)
  • Grazoprevir/Elbasvir, Merck’s Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations (Press)
  • Dr Reddy's files three new drug applications with USFDA (India Times) (Press)

US: Pharmaceuticals and Biotechnology: General

  • Hayman’s Bass Targets Shire in New Drug Patent Challenges (Bloomberg) (WSJ-$)
  • Biosimilar Costs Could Exceed Brands In Part D Coverage Gap (Pink Sheet-$)
  • Medicare Part D has led to an increase in opioid abuse (TIE)
  • AbbVie Says FTC Can't Fight By Own Rules In Pay-For-Delay (Law 360-$)

US: Medical Devices

  • FDA approach to medical device security is a step backward (GovHealthIT)
  • FDA recalls 440,000+ equipment drapes used by Intuitive Surgical (Fierce)
  • FDA says ReShape Medical can skip advisory panel for obesity balloon device (Mass Device)
  • Synaptive Medical Wins FDA Clearance for Groundbreaking Surgical System Brightmatter Guide (Press)
  • Alere earns FDA clearance for rapid diagnostic of Strep A (Fierce)

US: Dietary Supplements

  • Controversial sports supplement's return sparks outrage (USA Today)
  • Study Warns of Diet Supplement Dangers Kept Quiet by F.D.A. (NYTimes)
  • CRN asks FDA to enforce the law in supplement case (NewHope)

US: Assorted And Government

  • FDA open-data platform gains traction (MM&M)
  • Repurposing an “Old” Drug for Alzheimer’s Disease (NIH)
  • Regulatory Gigs Lure Prosecutors (WSJ-$)
  • FDA to Hold 2015 Science Forum (FDA)
  • FSMA Funding Far below Estimated Requirement (NYTimes)

Upcoming Meetings and Events

Europe

  • Europe’s Revised Biosimilars Guideline Allows Non-EU Data In Applications (Pink Sheet-$)
  • Mandatory use of eCTD for decentralised procedures (MHRA)
  • Avastin approved for cervical cancer in EU (PMLive) (Press)
  • Netherlands Medicines Evaluation Board says no ‘relevant differences’ between biosimilars, reference products (BioPharma Reporter)
  • EC Approves Santen's Ciclosporin (EC)
  • New Czech law on medical devices takes effect (SCRIP RA-$)
  • Managing medical devices (MHRA)

India

  • Merck KGaA takes on 'counterfeiters' in India (SCRIP-$)
  • Antibiotics to insulin: Key drugs to cost 4% more (India Times)

Japan

  • Pharmacopoeial Harmonization: Focus on Japan (USP)

China

  • Throwing light on China's clinical trial requirement (Clinica-$)

Australia

  • TGA reforms: A blueprint for TGA's future: Progress report (TGA)

Clinical Trials

  • Reporting Bias Rife in Antidepressant Studies for Anxiety (Medscape) (JAMA)

General Regulatory And Interesting Articles

  • 1,000 Year Old Remedy May Cure MRSA, Still Faces Market Hurdles (NatGeo)

Regulatory Reconnaissance #531 – 8 April 2015

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.


Categories: Recon, Regulatory News

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