Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Weekend Edition (27 - 28 July 2013)

Regulatory Reconnaissance: Weekend Edition (27 - 28 July 2013)

Posted 26 July 2013 | By Alexander Gaffney, RAC 

Welcome to a special weekend edition of Regulatory Reconnaissance, Focus' regulatory news and intelligence briefing.

Five in Focus From This Week

  • FDA Cracks Down on Indian Manufacturers, Citing New FDASIA Authority and Egregious Violations (Focus)
  • PhRMA, EFPIA Call for Clinical Data Transparency, but Principles Fall Short of EMA Proposal (Focus)
  • FDA Loses Major Case Testing its Enforcement Discretion Authority (Focus)
  • Modified Senate Legislation Emerges, Would Reform Compounding Regulation, Track and Trace (Focus)
  • New Guidance Clarifies Process for Bringing Drugs into US Prior to Approval to Expedite Market Access (Focus)

In Focus: US

  • FDA limits use of J&J's Nizoral antifungal drug on safety concerns (MedPage Today) (MedScape) (Bloomberg) (FDA) (FDA)
  • Groups Call on FDA, OMB for Final Device ID Rule (MedPage Today)
  • Weight loss: FDA accepts EnteroMedics' submission of VBLOC neurostim implant (Mass Device)
  • US court permits generic version of Teva MS drug a year sooner (Reuters) (Teva)
  • Muscular Dystrophy Drug Raises Superiority Issues In Breakthrough Path (IHP)
  • Teva Citizen Petition: Don't Approves Generics of Dose-Metered Inhaler (FDA)

In Focus: International

  • Novartis COPD drug gets European backing (Fierce) (Reuters)
  • Why China pays over the odds for its medicines (Reuters)
  • Mixed Results: A Closer Look At China's Essential Drug List System After Expansion (Pink Sheet)
  • India's Top Court Orders Government To Frame A Tight Policy For Clinical Trials (BioSpectrum) (PharmAsia)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA limits use of J&J's Nizoral antifungal drug on safety concerns (MedPage Today) (MedScape) (Bloomberg) (FDA) (FDA)
  • US court permits generic version of Teva MS drug a year sooner (Reuters) (Teva)
  • Muscular Dystrophy Drug Raises Superiority Issues In Breakthrough Path (IHP)
  • FDA Approves NDA for Luitpold's Injectafew (#203565) (FDA)
  • FDA Approves ANDA for Cipla's Zyrtec (Cetirizine HCl Allergy) (#077318) (FDA)
  • Teva Citizen Petition: Don't Approves Generics of Dose-Metered Inhaler (FDA)
  • FDA Quietly Announces Meeting on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (FDA)
  • Pharmacokinectic Sample Analysis for Ranolazine Dofetilide Verapamil and Quinidine Clinical Study (FBO)
  • Reagan-Udall Foundation Looking to Redesign Website (RU)
  • California Stem Cell Submits FDA Phase III Clinical Trial Protocol for the Treatment of Metastatic Melanoma (CSC)
Medical Devices
  • Groups Call on FDA, OMB for Final Device ID Rule (MedPage Today)
  • Weight loss: FDA accepts EnteroMedics' submission of VBLOC neurostim implant (Mass Device)
  • White-hat hacker who illuminated medical devices' cybersecurity woes has died (MedCity News)
Assorted And Government
  • Regulatory Czar Shelanski Testifies Before House Small Business Committee, Marks Shift in Policy (CPR)
  • FDA Advocacy at a Glance (Strengthen FDA)
  • Sunshine Act: What is a Journal Reprint Worth? (PharmExec)
Upcoming Meetings And Events
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 29 July 2013: Workshop on Clinical Development Programs for Opioid Conversion (FDA)
  • 30-31 July 2013: Workshop on Battery-Powered Medical Devices (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • 2 August 2013: Blood Products Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Novartis COPD drug gets European backing (Fierce) (Reuters)
  • CHMP gives green light to one more filgrastim biosimilar (SCRIP)

Asia

  • Why China pays over the odds for its medicines (Reuters)
  • Mixed Results: A Closer Look At China's Essential Drug List System After Expansion (Pink Sheet)
  • India's Top Court Orders Government To Frame A Tight Policy For Clinical Trials (BioSpectrum) (PharmAsia)
  • Orphan Drugs in Asia 2013: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market (Research and Markets)

Other International

  • Canadian caution led to fewer metal hip replacement problems (Fierce)

General Regulatory And Interesting Articles

  • Stomach Bug Spreads Across Midwest; Causes Anorexia (NPR)

Regulatory Reconnaissance #118  - 27 July 2013

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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe