Regulatory Focus™ > News Articles > Regulatory Recon: FDA's Woodcock Says Trials Transparency is up to Industry, Not FDA (9 June 2014)

Regulatory Recon: FDA's Woodcock Says Trials Transparency is up to Industry, Not FDA (9 June 2014)

Posted 09 June 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA's Woodcock Says Trials Transparency is up to Industry, Not FDA (9 June 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

  • FDA approves Biogen Idec’s haemophilia drug (FDA) (PMLive) (SCRIP-$) (Pharma Times) (BioCentury) (Reuters) (Boston Globe) (Press) (MedPage Today)
  • Woodcock says companies should take on trials transparency (BioCentury)
  • A Case of Mistaken Identity? Glaxo Faces a Lawsuit Over Generic Liability (Pharmalot)
  • CDISC Data Standard for Multiple Sclerosis Spurs Sharing of Clinical Data (CDISC)
  • GDUFA Facility List Lags Last Year, May Be Trailed By Higher Fees (Pink Sheet-$)
  • Draft Guidance Docs Should Be Transitory, Industry Insists (Gray Sheet-$)
  • Diagnostic Testing Fight Puts FDA In A Pickle (Law 360-$)
  • Coming Together On CLIA Waivers? Industry Hopes To Recruit Patients, Providers To Push Reform (Gray Sheet-$)

In Focus: International

  • French Transparency agency backs Gilead’s new hepatitis C drug Sovaldi (Pharma Letter-$)
  • Stricter EU measures unexpectedly paying off for notified bodies (Clinica-$)
  • Court tells Canadian feds: "you cannot control generic drug prices" (Pharma Times)
  • Is Global Variability in HTAs Limiting Patient Access to Important Medicines? (Context Matters)

US: Pharmaceuticals/Biotechnology

  • FDA approves Biogen Idec’s haemophilia drug (FDA) (PMLive) (SCRIP-$) (Pharma Times) (BioCentury) (Reuters) (Boston Globe) (Press) (MedPage Today)
  • Woodcock says companies should take on trials transparency (BioCentury)
  • A Case of Mistaken Identity? Glaxo Faces a Lawsuit Over Generic Liability (Pharmalot)
  • CDISC Data Standard for Multiple Sclerosis Spurs Sharing of Clinical Data (CDISC)
  • BioCenturyTV Interview with Janet Woodcock on Path to 21st Century Cures Initiative (BioCentury)
  • GDUFA Facility List Lags Last Year, May Be Trailed By Higher Fees (Pink Sheet-$)
  • USP Suggests “Group Monographs” To Augment OTC Drug Review (Tan Sheet-$)
  • Revised pCR Guidance Likely To Include Failed ALTTO Trial, FDA Says (Pink Sheet-$) (Pink Sheet-$)
  • Top Excipient DMF Problem Areas for FDA Include Authorization Letters, Paper Filings, and Annual Reports (IPQ-$)
  • FDA Review Should Be More Like Business Negotiation, Orexigen CEO Says (Pink Sheet-$)
  • Food and Drug Administration Responds to Pressure for Expanded Drug Access (JNCI-$)
  • BioDelivery Sciences Receives FDA Approval for BUNAVAIL (buprenorphine and naloxone) Buccal Film for the Maintenance Treatment of Opioid Dependence (Press) (Reuters)
  • FDA Oks Valeant Toenail Fungus Treatment Jublia (AP) (Press) (SCRIP-$)
  • FDA Approves Expanded Label for AZILECT for Treatment Across All Stages of Parkinson’s Disease (Press)
  • Bad medicine: The awful drug reactions Americans report (Washington Post)

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

  • GW hits the FDA fast track with its cannabis-based epilepsy drug (Fierce)
  • Supplemental New Drug Application for IMBRUVICA Accepted by the U.S. FDA and Priority Review Granted (Press)
  • US FDA grants Edison Pharmaceuticals’ EPI-743 orphan status for Leigh Syndrome (Pharma Letter-$) (PharmPro)
  • Cubist Posts Positive Pivotal Data for Novel Antibiotic (Press) (Press)
  • Momenta gets orphan designation for potential pancreatic cancer drug (BioFlash)

US: Pharmaceuticals and Biotechnology: General

  • The Aggregation Hoax and PIA (RxTrace)
  • Judge Voids Expansion of Discount Drug Program (NYTimes)
  • US Capitol Capsule: Consumer Rx loans, paying for big initiatives: BIO 2014 sizzlers (SCRIP-$)
  • One simple drug switch could save Medicare $18 billion over the next decade (Vox)
  • Ex-Merck exec’s new microbiome startup has a pill that works like a fecal transplant against C. diff (MedCity News)
  • Can we Afford Personalized Medicine? (Proto Mag)
  • Massachusetts Pharmaceutical and Device Code of Conduct: Companies Won’t Have to Report Payments Covered by Federal Sunshine Act; Gift Ban Still In Place (Policy and Medicine)

US: Medical Devices

  • Draft Guidance Docs Should Be Transitory, Industry Insists (Gray Sheet-$)
  • Diagnostic Testing Fight Puts FDA In A Pickle (Law 360-$)
  • Coming Together On CLIA Waivers? Industry Hopes To Recruit Patients, Providers To Push Reform (Gray Sheet-$)
  • FDA experts issue mixed vote on Kamra vision-improving implant (Mass Device)
  • When it comes to clinical-decision software, what does autonomy mean? (Modern Healthcare)
  • FzioMed to get AdComm Review of PMA Denial (FDA)
  • FDA too restrictive on medical devices, Sysmex CEO says (Lincolnshire Review)
  • Companion Diagnostics for Targeted Cancer Drugs - Clinical and Regulatory Aspects (NCBI)
  • In Setback, FDA Asks Epigenomics For More Data To Support Colon Cancer Test (Gray Sheet-$)

US: Dietary Supplements

  • Meth Analogues a New Trend in Supplement Adulteration (NPI)
  • FSMA Gives FDA Access to Records During Emergencies (NPI)

US: Assorted And Government

  • FDA Still Stretched Too Thin to Accomplish Its Mission (Strengthen FDA)
  • E&C Committee Markup on Several Regulatory Bills This Week (E&C)

Europe

  • French Transparency agency backs Gilead’s new hepatitis C drug Sovaldi (Pharma Letter-$)
  • Stricter EU measures unexpectedly paying off for notified bodies (Clinica-$)
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 June 2014 (EMA)
  • on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States (EurLex)
  • SCENIHR Calling for Public Input on Synthetic Biology (SCENIHR)

India

  • Expert panel on FDC to assess safety, efficacy of several FDCs on June 11 (PharmaBiz)

Japan & China

  • Tsinghua University And J&J Join On Respiratory Research, Talk Regulatory Push For Drug Development (PharmAsia-$)

Canada

  • Court tells Canadian feds: "you cannot control generic drug prices" (Pharma Times)

Other International

  • Is Global Variability in HTAs Limiting Patient Access to Important Medicines? (Context Matters)
  • Updated ISO 13485 Requirements from Egyptian Ministry of Health (Mass Device)
  • Biologics prices prompt WHO call for affordable biosimilars (BioPharma Reporter)

General Regulatory And Interesting Articles

  • The Latest Buzz in Pain Medicine is a Device That Looks like a Cartoon Bee (MedGadget)

Regulatory Reconnaissance #334 – 9 June 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.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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