Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Biosimilars Naming Guidance to Precede Approvals, FDA Says (6 February 2

Regulatory Reconnaissance: Biosimilars Naming Guidance to Precede Approvals, FDA Says (6 February 2014)

Posted 06 February 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • FDA Wants Biosimilar Naming Guidance Released Before Approving An Application (Pink Sheet-$)
  • Company Study of Pradaxa Caused a Debate Over Key Selling Point, Records Show (NYTimes)
  • CDRH's Jeffery Shuren on 2014/2015 Priorities (Gray Sheet-$)
  • J&J destroyed thousands of files on vaginal mesh implants, judge says (Bloomberg) (Law 360-$)
  • Biosimilars name, notification debates rage on, but costs still 'elephant in the room' (SCRIP-$) (BioPharma Reporter) (MM&M)
  • India DCGI To Urge U.S. FDA Head To Make Own Makers Follow Trial Rules (PharmAsia-$) (India Times)

In Focus: International

  • Prepare to update all your EU product info, EMA tells companies (SCRIP-$)
  • EU Drug Regulator Said To Have Called DCGI Over Ranbaxy Concerns (PharmAsia-$)
  • EMA Finalizes, Releases ICH M8 Guideline on eCTD (EMA)
  • Indian Health Minister Expresses Concern About Industry Reputation After Regulatory Lapses (PharmaBiz)
  • Gilead to license hepatitis C drug to lower-cost manufacturers in India (India Times) (Pharmafile) (Reuters)

US: Pharmaceuticals/Biotechnology

  • FDA Wants Biosimilar Naming Guidance Released Before Approving An Application (Pink Sheet-$)
  • Company Study of Pradaxa Caused a Debate Over Key Selling Point, Records Show (NYTimes)
  • Big Pharma pushes for U.S. action against India over patent worries (Reuters)
  • Biosimilars name, notification debates rage on, but costs still 'elephant in the room' (SCRIP-$) (BioPharma Reporter) (MM&M)
  • India DCGI To Urge U.S. FDA Head To Make Own Makers Follow Trial Rules (PharmAsia-$) (India Times)
  • Quality Metrics Could Spur Drug GMPs Compliance, But Pose Risks (Tan Sheet-$)
  • Public Citizen Urges FDA not to Approve Droxidopa, Citing "Insufficient Evidence" (Public Citizen)
  • 2013 Year in Review: OPDP Warning Letters and Untitled Letters  (K&S)
  • FDA Warning on Health Risks in Testosterone Draws Lawsuits for Abbott, Abbvie (IBJ) (Bloomberg) (Law 360-$)
  • Compliance: Walking the Line (PharmExec)
  • FDA Enhances Website Searchability (FDA)
  • GPhA Infographic on FDA's Proposed Generic Drug Labeling Rule (GPhA)
  • Building a Case - AdComm Preparation (Eye on FDA)
  • Daiichi says new API import ban will affect Ranbaxy's US ops (In-Pharma)

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

  • AstraZeneca quietly sweeps out some notable mid-stage drug programs (Fierce)
  • Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for Beleodaq (belinostat) for Injection, a novel pan-HDAC inhibitor (Press)
  • Sarepta Therapeutics Announces Eteplirsen Demonstrates Stability on Pulmonary Function Tests through 120 Weeks in Phase IIb Study in Duchenne Muscular Dystrophy (Press)
  • GSK is refusing to write off its cancer vaccine despite last year's PhIII flop (Fierce)
  • GlaxoSmithKline reloads its pipeline with new PhIII drugs following approvals, setbacks (Fierce)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • CDRH's Jeffery Shuren on 2014/2015 Priorities (Gray Sheet-$)
  • J&J destroyed thousands of files on vaginal mesh implants, judge says (Bloomberg) (Law 360-$)
  • CDRH's Standards for its Custom Service Interactions (FDA)
  • Covidien Receives U.S. FDA 510(k) Clearance for Reinforced Stapling Reload Technology (Press)
  • B. Braun Receives FDA Approval For Next Generation 1L Intravenous Containers (Press)
  • Exact will make its case on March 27 for FDA approval of a colon cancer Dx (Fierce) (Press)

US: Dietary Supplements

  • FDA: Safety push will fall short without more funding (The Hill) (Law 360-$)
  • Labeling Beverages And Supplements Post-FDA Guidance (Law 360-$)
  • Nutrition Council Backs FTC Dissent On Health Ad Standard (Law 360-$)

US: Assorted And Government

Upcoming Meetings And Events

  • 10 February 2014: E&C Committee on Drug Shortage Problem (E&C)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Prepare to update all your EU product info, EMA tells companies (SCRIP-$)
  • EU Drug Regulator Said To Have Called DCGI Over Ranbaxy Concerns (PharmAsia-$)
  • EMA Finalizes, Releases ICH M8 Guideline on eCTD (EMA)
  • NICE reviews lung cancer drug guidance (PMLive)
  • Edwards wins wider use for an older model Sapien heart valve in Europe (Fierce)
  • Three ways Scottish HTA reforms could benefit pharma (SCRIP-$)
  • Six ABPI Code breaches for HRA Pharma (Pharmafile)
  • UK Approves New Botox Use (Press)

India

  • Indian Health Minister Expresses Concern About Industry Reputation After Regulatory Lapses (PharmaBiz)
  • Gilead to license hepatitis C drug to lower-cost manufacturers in India (India Times) (Pharmafile) (Reuters)
  • India's Ranbaxy faces more regulatory scrutiny after U.S. ban (Reuters)
  • CDSCO sets up 10 expert panels to evaluate safety of FDCs permitted without due approval (PharmaBiz)
  • Ranbaxy Talks Up De-risking Strategy To Offset Impact Of Toansa Site Ban (PharmAsia-$)

Japan & China

  • Japan Committee On Drugs Approves Astellas' Xtandi And Taiho's Colorectal Cancer Therapy (PharmAsia-$)

Other International

  • Canada: Health Canada Issued Warning on Blood Pressure Drugs (Health Canada)

General Regulatory And Interesting Articles

  • Why drug discovery is hard - Part 4: Taking the fight to the "enemy". (Scientific American)
  • To Catch a Killer Gene: Sisters Race to Stop Mystery Disease (NBC)
  • Bionic hand allows amputee to feel again (Reuters) (NPR) (IEEE)
  • Electronically controlled drugs could minimize side effects (Press)

Regulatory Reconnaissance #251 - 6 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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