Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA, India Strengthen Inspection Ties (11 February 2014)

Regulatory Reconnaissance: FDA, India Strengthen Inspection Ties (11 February 2014)

Posted 11 February 2014 | By Alexander Gaffney, RAC

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In Focus: US

In Focus: International

  • Updated EU biosimilar guidance expected in next few months (SCRIP-$)
  • EU rules 'mean children can't get life-saving cancer drugs' (EurActiv) (SCRIP-$) (Reuters) (Press) (Guardian) (AP)
  • France's ANSM Unveils "Cancer Plan," Intends to Expedite "Fast Access" to Medicines (ANSM)
  • EMA clarifies interpretation of new variation classification categories (EMA)
  • India to discuss 'informally' 'disproportionate' action against Indian pharmaceutical firms with US (India Times)
  • Affordable drugs don't mean spurious: Indian Health Minister tells US (India Times) (In-Pharma) (PharmAsia-$)
  • India said it will take its time revamping medical device and drug regulations (Fierce)

US: Pharmaceuticals/Biotechnology

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

US: Pharmaceuticals and Biotechnology: General

  • America's Plan B problem: The contraception misinformation epidemic (Salon)
  • Prescription Painkillers Seen as a Gateway to Heroin (NYTimes)
  • An Antibiotic Anniversary Celebration: Deal-Making and Investment Are Active In Formerly Moribund Field (RPM Report-$)
  • PhRMA Moves To Vanquish FTC Rule Targeting Drugmakers (Law 360-$)

US: Medical Devices

  • FDA's Focus On Postmarket Device Data Poses Reimbursement Challenge (IHP-$)
  • Antiquated Nebulizers Deliver Uneven Asthma Doses - FDA Reviewers (Tan Sheet-$)
  • CDS Coalition Says It Is Premature For Lawmakers To Legislate FDA's HIT Paradigm (IHP-$)
  • 'Lung In A Box' Keeps Organs Breathing Before Transplants (NPR)
  • Should patients have direct access to their lab results? (CBS)
  • Tandem Diabetes Recalls Insulin Cartridges at Risk for Leaking (FDA)
  • CABANA trial morphs from mortality trial to composite endpoint trial (Mass Device)
  • CareFusion Settlement Features Corporate Regulatory Officer as Whistle Blower, Implicating High Profile Physicians (Policy and Medicine)
  • PRECICE 2 Limb Lengthening System Cleared by FDA (MedGadget)
  • Hamilton Medical's MRI Compatible Ventilator Cleared in U.S. (MedGadget)
  • FDA clears two wristworn fitness trackers for clinical trials (Mobi Health News)

US: Dietary Supplements

  • FTC Files Brief in POM Wonderful LL Appeal Arguing First Amendment Protection Is not Available for POM's Allegedly Misleading Claims (FDA Law Blog)

US: Assorted And Government

  • How Chris Christie and BMS Changed the Rules for Federal Prosecutors (Washington Post)
  • Notice of Kidney Interagency Coordinating Committee Meeting (NIH)

Upcoming Meetings And Events

  • 10 February 2014: E&C Committee on Drug Shortage Problem (E&C)
  • 10-11 February 2014: Joint Meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Meeting (FDA)
  • 12 February 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 13 February 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 14 February 2014: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Updated EU biosimilar guidance expected in next few months (SCRIP-$)
  • EU rules 'mean children can't get life-saving cancer drugs' (EurActiv) (SCRIP-$) (Reuters) (Press) (Guardian) (AP)
  • France's ANSM Unveils "Cancer Plan," Intends to Expedite "Fast Access" to Medicines (ANSM)
  • EMA clarifies interpretation of new variation classification categories (EMA)
  • Concerns over big pharma links to NHS policy (Pharmafile) (Guardian)
  • Germany looks again at Fycompa pricing (PMLive)
  • B. Braun's Coroflex ISAR receives CE mark (Press)
  • pSivida Announces ILUVIEN for DME Accepted by National Health Service Scotland (Press) (PharmaTimes)
  • Immigration quotas could have knock-on effect on pharma industry recruitment (Pharma Letter-$)

India

  • India to discuss 'informally' 'disproportionate' action against Indian pharmaceutical firms with US (India Times)
  • Affordable drugs don't mean spurious: Indian Health Minister tells US (India Times) (In-Pharma) (PharmAsia-$)
  • India said it will take its time revamping medical device and drug regulations (Fierce)
  • Doctors Call For Stronger Regulations For New Vaccines In India (Kaiser)
  • Wockhardt's earnings crash under the weight of FDA bans (Fierce)
  • Do not support sabotage theory for Toansa plant: Ranbaxy (India Times)

Japan & China

  • China Simplifies Medical Device Re-registration in 2014 (Mass Device)
  • Japanese delay for mogamulizumab in first line ATL (SCRIP-$)

Other International

  • Africa: EAC set to finalize processes of medicines registration and regulation (PharmAfrica)
  • Drug Firms Look to Gulf Region as Next Frontier (WSJ-$)
  • Aegerion wins Health Canada OK for Juxtapid in HoFH (SCRIP-$)
  • Poor Nations Seek New Hepatitis C Drug (NYTimes)

General Regulatory And Interesting Articles

  • Precise and easy ways to rewrite human genes could finally provide the tools that researchers need to understand and cure some of our most deadly genetic diseases. (MIT Tech Review)
  • Do Some Drugs Become Dangerous After Expiration? (NYTimes)

Regulatory Reconnaissance #254 - 11 February 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.

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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