Regulatory Focus™ > News Articles > Regulatory Reconnaissance (19 December 2013)

Regulatory Reconnaissance (19 December 2013)

Posted 19 December 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

Your editor will be on break for the Holiday starting 21 December 2013, and returning on 2 January 2014. Regulatory Reconnaissance will not be published during this time.

In Focus: US

In Focus: International

  • India's Wockhardt Cited In Another U.S. FDA 'Import Alert," For Vet Plants (PharmAsia-$)
  • Daiichi to help Ranbaxy meet US FDA norms (The Hindu)
  • Chinese regulators to launch simplified registration renewal process in 2014 (Mass Device)
  • Registration opens for joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop (EMA) (EMA)
  • European Medicines Agency closed 23 December 2013 to 2 January 2014 (EMA)

US: Pharmaceuticals/Biotechnology

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

US: Pharmaceuticals and Biotechnology: General

  • Pharma displaying 'pathological lack of corporate integrity' (Pharmafile)
  • Many doctors report trouble getting cancer drugs (Reuters)

US: Medical Devices

  • FDA allows marketing of new stent for treating pseudocysts of the pancreas (FDA)
  • Applying Text Mining to Medical Device Recalls (MedDevice Summit)
  • Stryker Inks 1st Settlements In NJ Hip Implant Suits (Law 360-$) (Mass Device) (Fierce)
  • The FDA vs. 23andMe: A Lesson for Health Care Entrepreneurs (Wharton)
  • FDA Clears the Provant Therapy System for Use by Patients with Metallic Implants (Press)
  • American Medical Systems wins 510(k) clearance for transvaginal sling (Fierce)
  • Medtronic kicks off another renal denervation trial as competitors lag behind (Fierce)

US: Assorted And Government

  • Medical Food Draft Guidance - Has the FDA Bitten Off More than it Can Chew? (FDA Law Blog)
  • Budget victory! But NIH, FDA could still be appropriations losers (SCRIP-$) (Gray Sheet-$)
  • Enforcement Report - Week of December 18, 2013 (FDA)

Upcoming Meetings And Events

  • 10 January 2013: National Biodefense Science Board Meeting (DHHS)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Registration opens for joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop (EMA) (EMA)
  • European Medicines Agency closed 23 December 2013 to 2 January 2014 (EMA)
  • IQWiG view on Roche's Zelboraf unchanged despite new data (Pharma Letter-$)
  • Reverse Medical® Corporation Announces CE Mark Approval and Initial Clinical Use of the BARREL Vascular Reconstruction Device for the Treatment of Intracranial Bifurcation Aneurysms (Press)

Asia

  • India's Wockhardt Cited In Another U.S. FDA 'Import Alert," For Vet Plants (PharmAsia-$)
  • Daiichi to help Ranbaxy meet US FDA norms (The Hindu)
  • Chinese regulators to launch simplified registration renewal process in 2014 (Mass Device)
  • India confirms 50 trials meet standards (SCRIP-$)
  • China continues drive to upgrade medical device regulatory standards (SCRIP-$)

Other International

  • Brazil's ANVISA and ProGenericos sign cooperation agreement (Pharma Letter-$)
  • Australia: TGA business plan 2013-2014 (TGA)
  • Genzyme's Lemtrada Approved in Australia for Treatment of Multiple Sclerosis (Press)

General Regulatory And Interesting Articles

  • Scientists start to unpick narcolepsy link to GSK flu vaccine (Reuters)
  • Antidepressants taken in pregnancy don't cause autism (Reuters)
  • Big Data, Big Pharma, Big Privacy Catastrophe (Forbes)
  • Dissolvable batteries are on their way for the ingestible medical devices of the future (Fierce)
  • Moderate alcohol consumption acts as vaccine adjuvant in monkeys (Fierce)
  • Taking HIV prevention pill may not encourage risky sex: U.S. study (Reuters)

Regulatory Reconnaissance #225 - 19 December 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.


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