Regulatory Focus™ > News Articles > Regulatory Recon: Indian Drug Regulator Called a 'Snake Pit of Vested Interests (23 July 2014)

Regulatory Recon: Indian Drug Regulator Called a 'Snake Pit of Vested Interests (23 July 2014)

Posted 23 July 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Indian Drug Regulator Called a 'Snake Pit of Vested Interests (23 July 2014)

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In Focus: US

  • Every fifth FDA Warning Letter includes deficiencies regarding Equipment (ECA)
  • Can E&C Lift the Off-Label Gag Order? (DrugWonks) (Pink Sheet-$)
  • PMA Data: High Approval Volume, Reduced Supplement Review Time For May (Gray Sheet-$)
  • JAMA: Power morcellator devices increase levels of undetected cancers in women (Fierce) (WSJ-$) (WaPo) (NYTimes)
  • FDA 510(k) Risk-Benefit Guide Oversteps Regulatory Bounds, Attorney Says (IHP-$)

In Focus: International

  • India's Health Minister Calls CDSCO a "Snake Pit of Vested Interests" (India Times) (Reuters)
  • Report: GSK Flu Vaccine Plant Inspection Finds Ten Actionable Issues (PharmPro)
  • Russian regulators preparing new medical device classification system? (Mass Device)
  • French Off-Label Law To Be Forced Through Parliament, Driven By Avastin (Pink Sheet-$)
  • St. Jude flexible cardiac catheter approved in EU, aims for FDA (Fierce) (Mass Device)
  • European Pharma Races to Catch Up with Data Protection (PharmExec)
  • What the EU’s Proposed IVD Regulation Means for You (MDDI)

US: Pharmaceuticals and Biotechnology

  • A Legal Test for a Celgene's Off-Label Cancer Treatment (Bloomberg)
  • Every fifth FDA Warning Letter includes deficiencies regarding Equipment (ECA)
  • Can E&C Lift the Off-Label Gag Order? (DrugWonks) (Pink Sheet-$)
  • A Dearth in Innovation for Key Drugs (NYTimes)
  • PhRMA Wants Fewer Resrictions on Advertising and Promotions (PhRMA)
  • Research Consortia Need Funding, But FDA Is More “Honest Broker” (Pink Sheet-$) (SCRIP-$)
  • Eagle Pharma nabs FDA OK for hyperthermia drug  (Fierce) (Press)
  • Alli Labels In U.S. Add Seizure Advisory Similar To E.U. Change (Tan Sheet-$)
  • HDMA ASN Guidelines for DSCSA Implementation Updated (TraceLink) (RxTrace)
  • Turkish Man Pleads Guilty to Smuggling Fake Cancer Drugs Into U.S. (WSJ-$)
  • FDA Wants Solicitations About its Safe Use Initiative (FDA)

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

  • Puma shares triple on positive PhIII neratinib data, plans to file for approval (Fierce) (Press) (SCRIP-$) (Pharma Times) (Reuters)
  • Sage takes to the FDA fast track with its lead rare disease drug  (Fierce) (Press) (Press)
  • UCB reports positive Phase III results for brivaracetam in epilepsy (Pharma Letter-$) (Pharma Times)
  • Viiv's Selzentry HIV combo fails PhIII, but disappointment mild (SCRIP-$)
  • Dompe announces the Food and Drug Administration (FDA) has granted orphan drug designation to its rhNGF-based treatment for neurotrophic keratitis (Press)

US: Pharmaceuticals and Biotechnology: General

  • HIV pill Truvada shows more promise against infection (CBS)
  • States that deny anti-psychotics to the poor have lots of mentally ill people behind bars (Vox)
  • Jay-Z and Scarface: pharma staff’s anonymous Wikipedia interests (In-Pharma)

US: Medical Devices

  • PMA Data: High Approval Volume, Reduced Supplement Review Time For May (Gray Sheet-$)
  • Dean Kamen: Don't Blame Regulators for Stalling Medtech Innovation (MDDI)
  • JAMA: Power morcellator devices increase levels of undetected cancers in women (Fierce) (WSJ-$) (WaPo) (NYTimes)
  • FDA 510(k) Risk-Benefit Guide Oversteps Regulatory Bounds, Attorney Says (IHP-$)
  • FDA Recall of Advocate RediCode Blood Glucose Test Strips (FDA)

US: Assorted And Government

  • How Should Medical Information be Shared Amongst Life Science Companies and Patients? (E&C)
  • House Committee to Meet on Nanotech Innovation (E&C)

Europe

  • French Off-Label Law To Be Forced Through Parliament, Driven By Avastin (Pink Sheet-$)
  • St. Jude flexible cardiac catheter approved in EU, aims for FDA (Fierce) (Mass Device)
  • European Pharma Races to Catch Up with Data Protection (PharmExec)
  • UK's NICE changes guidance to recommend Eli Lilly’s Efient for blood clots (Pharma Letter-$) (Pharma Times) (Pharma Times)
  • UK’s NICE recommends Xtandi and Yervoy under patient access schemes (Pharma Letter-$) (PMLive) (Pharmafile)
  • What the EU’s Proposed IVD Regulation Means for You (MDDI)
  • European Pharmacopoeia plans revisions of elemental impurities guideline (In-Pharma)
  • Regulatory information – new formatted table template to be used in selected veterinary procedural submission cover letters (EMA)
  • Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (EMA)
  • Concept paper on use of aminoglycosides in animals in the European Union: Development of resistance and impact on human and animal health (EMA)
  • Guideline on the demonstration of palatability of veterinary medicinal products (EMA)
  • ICH guideline E2B (R3) on electronic transmission of individual case safety reports (ICSRs) - implementation guide - data elements and message specification (EMA)
  • ICH guideline Q4B annex 6 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on uniformity of dosage units – general chapter (EMA)

India

  • India's Health Minister Calls CDSCO a "Snake Pit of Vested Interests" (India Times) (Reuters)
  • Exporters want India & Vietnam to work together on addressing drug testing issues in Vietnam (PharmaBiz)

China

  • Chinese Officials Seal Off 'Plague' City, Puzzling US Experts (LiveScience)

Japan

  • Japanese Guidelines For Five Cancers Released Through NCCN (PharmAsia-$)

Canada

  • Report: GSK Flu Vaccine Plant Inspection Finds Ten Actionable Issues (PharmPro)
  • Policy on Drug/Medical Device Combination Products – Decisions (HC)
  • A Supplement is a Supplement, or is it? (NPI)

Other International

  • Russian regulators preparing new medical device classification system? (Mass Device)

Clinical Trials

  • Nine tips for designing reimbursement-ready ablation catheter trials (Clinica-$)
  • Biosimilar trials: the ‘under the radar’ sourcing race (Outsourcing Pharma)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #363 – 23 July 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.

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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