Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Concerns Grow About Indian Drug Quality (18 March 2014)

Regulatory Reconnaissance: Concerns Grow About Indian Drug Quality (18 March 2014)

Posted 18 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • Unease grows among U.S. doctors over Indian drug quality (Reuters)
  • State AGs to FDA: Reverse Zohydro painkiller approval (Newsday)
  • Chinese API Manufacturers put on FDA Import Alert (FDA)
  • Pierre Fabre Gains FDA Approval For Infantile Hemangioma Drug (AP) (Press)
  • Drug Off-Label Case Uses Medical Device Tactic To Avoid CMS Exclusion (IHP-$)
  • FDA Hiring a Senior Regulatory Science Program Director for its Office of Regulatory Affairs (FDA)

In Focus: International

  • Slippery Slope: How NICE breaks new ground linking price of Soliris to Alexion's R&D investment (BioCentury-$) (BioCentury-$)
  • Samsung's Galaxy S5 smartphone escapes med device label in S. Korea (Fierce)
  • NICE speeds BI's Giotrif through appraisal process (SCRIP-$) (BioCentury)
  • Indian Committee to have greater say in waiving local clinical requirement for foreign drugs (PharmaBiz)
  • A Quarter of Doctors in Europe Can't Define Biosimilars (Bloomberg)
  • Tokyo hospital exec says Novartis employees deeply involved in leukemia-drug trial (Fierce)

US: Pharmaceuticals/Biotechnology

  • Unease grows among U.S. doctors over Indian drug quality (Reuters)
  • State AGs to FDA: Reverse Zohydro painkiller approval (Newsday)
  • Video Debate: Richard Epstein and Ryan Abbott on FDA Involvement in Off-Label Drug Use (Harvard BOH)
  • Questions raised on safety issues and costs related to 'direct-to-consumer' advertising (MNT)
  • Chinese API Manufacturers Zhejiang Jiuzhou Pharmaceutical, Zhejiang Zonebanne put on FDA Import Alert (FDA)
  • Pierre Fabre Gains FDA Approval For Infantile Hemangioma Drug (AP) (Press)
  • ASCO provides perspective on clinically meaningful outcomes (BioCentury)
  • Avedro Announces Receipt of Complete Response Letter from FDA for Corneal Cross-Linking NDA (Press)
  • Shire lays blame for Vpriv recall at feet of contractor (Fierce)
  • Pfizer sues over Viagra generic (Pharmafile) (Bloomberg)
  • Natco Pharma gets USFDA tentative nod for generic Tamiflu (India Times)
  • Retiring Rep. Waxman on biosimilars, 'dual-eligibles,' Part D, pharma profits (BioCentury)
  • Is the FDA Getting It Right with Accelerated Review? The Advocate's View (Life Science Leader)
  • Who "lost" Abuse Deterrence? (Drug Wonks)
  • Karen Noonan to Head Global Regulatory Policy for ACRO (Press)

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

  • Phase 4 Actelion Study Misses Primary Endpoint (Forbes)
  • FDA delays decision on Biogen's multiple sclerosis drug (Reuters) (Press)
  • Positive new Ph III data from Janssen's once-daily simeprevir presented at APASL (Pharma Letter-$)

US: Pharmaceuticals and Biotechnology: General

  • Drug Off-Label Case Uses Medical Device Tactic To Avoid CMS Exclusion (IHP-$)
  • Okla. Out Of Execution Drug (PharmPro)

US: Medical Devices

  • FDA Publishes Meeting Materials for 20 March Gastroenterology-Urology Devices AdComm Meeting (FDA)
  • FDA: Biotronik can expand its MRI-safe ICD trial (Fierce)
  • Op-Ed: Update FDA's Health IT Policy Now (Roll Call)

US: Dietary Supplements

  • Supplements Not Excluded from FDA's Proposed Nutrition Label Changes (NPI)
  • US: Assorted And Government
  • FDA Hiring a Senior Regulatory Science Program Director for its Office of Regulatory Affairs (FDA)

Europe

  • Slippery Slope: How NICE breaks new ground linking price of Soliris to Alexion's R&D investment (BioCentury-$) (BioCentury-$)
  • CMDh updates country requiremens for new applications and lifecycle submissions (Exalon)
  • NICE speeds BI's Giotrif through appraisal process (SCRIP-$) (BioCentury)
  • Germany rebuffs Aegerion's Lojuxta (BioCentury)
  • IQWiG rebuffs first-line use of BMS's Yervoy (BioCentury)
  • EMA Working With New EU Network Data Board (EMA) (EMA)
  • French formalize off-label use of baclofen in alcoholism (SCRIP-$)

India

  • Apex committee on clinical trials to have greater say in waiving off requirement for local trials for foreign drugs (PharmaBiz)

Japan & China

  • AHWP to Launch New Safety Alert Dissemination System (AHWP)
  • Tokyo hospital exec says Novartis employees deeply involved in leukemia-drug trial (Fierce)
  • Janssen Japan Files For Approval Of 600 mg Prezista Tablets For HIV (PharmAsia-$)
  • Daiichi Sankyo Files NDA in Japan for Toxic Blood Drug (Press)
  • Japan clearance for mogamulizumab in PTCL/CTCL (SCRIP-$)

Other International

  • Samsung's Galaxy S5 smartphone escapes med device label in S. Korea (Fierce)
  • Australia Warns About Reports of Melanoma in Tysabri (Biogen Idec) Patients (TGA) (Pharma Letter-$)
  • Big Pharma Presses Australia Gov't to End Poppy Monopoly (PharmaManufacturing)

General Regulatory And Interesting Articles

  • A Quarter of Doctors in Europe Can't Define Biosimilars (Bloomberg)

Regulatory Reconnaissance #278 - 18 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.

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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