Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Can India Hold its Drug Companies to US Standards? (27 January 2014)

Regulatory Reconnaissance: Can India Hold its Drug Companies to US Standards? (27 January 2014)

Posted 27 January 2014 | By Alexander Gaffney, RAC 

Regulatory Reconnaissance: Top Indian Regulator Says Industry Can't be Held to US Standards (27 January 2014)

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.

In Focus: US

  • No serious side effects with Merck allergy pill: FDA documents (Reuters) (Pink Sheet-$)
  • Adverse Events In Social Media: FDA Expects Signal Detection "Revolution" (Pink Sheet-$)
  • Former FDA Commissioner: Innovation "Imperative" (The Hill)
  • NME Sponsors Followed PDUFA V's "Program" To Advisory Committee Success In 2013 (Pink Sheet-$)
  • Attorneys, FDA Hit The Road To Instruct On Mobile Health Regs (Gray Sheet-$)
  • NIH's NCATS Turns Two: How the Center is Trying to Upend Drug Development (BioCenturyTV)

In Focus: International

  • Top Indian Regulator: Indian Companies Can't be Judged by US Standards (LiveMint) (India Times)
  • More Than 500 Chinese Pharmas Suspended For Failure To Meet GMP Standards (PharmAsia-$)
  • Flies in Ranbaxy's Toansa plant's sample storage room,says FDA (India Times)
  • Are Indian pharma companies overdosing on lethal drug of fraud? (India Times)
  • NICE rejects "wider societal benefit" test for new drugs (Pharma Times)
  • EMA Releases NSAID Study Guideline (EMA)

US: Pharmaceuticals/Biotechnology

  • No serious side effects with Merck allergy pill: FDA documents (Reuters) (Pink Sheet-$)
  • Adverse Events In Social Media: FDA Expects Signal Detection "Revolution" (Pink Sheet-$)
  • Former FDA Commissioner: Innovation "Imperative" (The Hill)
  • NME Sponsors Followed PDUFA V's "Program" To Advisory Committee Success In 2013 (Pink Sheet-$)
  • 5 Takeaways From FDA Overture On Generic-Drug Approvals (Law 360-$)
  • FDA reschedules fibromyalgia meeting (BioCentury) (FDA)
  • IV Saline in Short Supply (MedPage Today)
  • Cantrell Drug Company Updates FDA Registration to 503B Outsourcing Facility (Press)
  • How the DQSA Will-And Won't-Protect The Supply Chain, Part 2 (RxTrace)

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

  • Pfizer says lung cancer drug fails two late-stage studies (Reuters) (Fierce) (Press)
  • Positive Phase III top-line results for Endo/BDSI pain drug (SCRIP-$)
  • Otsuka/Lundbeck say brexpiprazole works in phase III trial (PMLive)
  • Financial woes are threatening Advanced Cell Technology, running the only FDA-approved clinical trials of embryonic stem-cell therapies (Scientific American)

US: Pharmaceuticals and Biotechnology: General

  • At $84,000 Gilead Hepatitis C Drug Sets Off Payer Revolt (Bloomberg)
  • PCORI's Selby Expects More Drug-Related Comparative Research In 2014 (Pink Sheet-$) (PCORI) (PCORI)
  • McNeil promotes OTC safety with new website (DSN)
  • Parents Press for Pot-Based Remedy (WSJ-$)
  • NY Bill to Report Marketing Expenses Moves Forward (NY)

US: Medical Devices

  • Attorneys, FDA Hit The Road To Instruct On Mobile Health Regs (Gray Sheet-$)
  • FDA Issues New Draft Guidance for Custom Devices; Some Points Worth Highlighting (FDA Law Blog)
  • AtheroMed Announces FDA Clearance To Market The Phoenix Atherectomy System For Treating Peripheral Artery Disease (Press)

US: Assorted And Government

  • NIH's NCATS Turns Two: How the Center is Trying to Upend Drug Development (BioCenturyTV)
  • Agonizing Choices for Lives Saved by Miracle Drugs (WSJ-$)
  • US Capitol Capsule: Tangling with drivers, barriers of biosimilar competition (SCRIP-$)
  • Silencing Many Hospital Alarms Leads To Better Health Care (NPR)

Upcoming Meetings And Events

  • 28 January 2014: Allergenic Products Advisory Committee Meeting (FDA)
  • 28 January 2013: US State of the Union Address (White House)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 29-30 January 2014: Science Advisory Board to the National Center for Toxicological Research Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • NICE rejects "wider societal benefit" test for new drugs (Pharma Times)
  • EMA Releases NSAID Study Guideline (EMA)
  • Call for strategic regulatory rethink for EU generic medicines industry (Pharma Letter-$)
  • CHMP recommends EU approval of a new formulation of Roche's MabThera for patients with non-Hodgkin lymphoma (Press) (Reuters)
  • Declare yourself! UK sports nutrition firm calls out 'proprietary blend' ingredient concealment (Food Quality News)

India

  • Flies in Ranbaxy's Toansa plant's sample storage room,says FDA (India Times)
  • How Ranbaxy lost sight of a vision in pursuit of short-term profit (LiveMint)
  • Are Indian pharma companies overdosing on lethal drug of fraud? (India Times)
  • Top Indian Regulator: Indian Companies Can't be Judged by US Standards (LiveMint) (India Times)
  • Indian Drug Regulator Calls for Establishment of New Administrative Service Dedicated to Drug Regulation (PharmaBiz)

Japan & China

  • More Than 500 Pharmas Suspended For Failure To Meet GMP Standards (PharmAsia-$)

Other International

  • New Zealand Doctors Argue Over Lack Of Warnings In Drug Ads (PharmAsia-$)
  • Sri Lanka Eyes Own Possible Ban On Imports From Ranbaxy Plants (PharmAsia-$)
  • Canada: Consultation on the Draft Guidance Document: Quality (Chemistry and Manufacturing): New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs); and the Certified Product Information - Chemical Entities (CPID-CE) Guidance Document and Template (Health Canada)

Regulatory Reconnaissance #243 - 27 January 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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