Regulatory Focus™ > News Articles > Regulatory Recon: Are States Pushing Expanded Access too Far? (20 May 2014)

Regulatory Recon: Are States Pushing Expanded Access too Far? (20 May 2014)

Posted 20 May 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Are States Pushing Expanded Access too Far? (20 May 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

  • The False Hope Of Colorado's 'Right To Try' Act (Forbes) (NBC)
  • CDER’s New Quality Office Still Awaiting Final Sign Offs (RPM Report-$)
  • FDA Power v. State Laws: Compounders Want Clarity On Office Use (Pink Sheet-$)
  • FDA Progress on the 2012 Drug Innovation Report by the President’s Council of Advisors on Science and Technology (FDA)
  • From Suppliers To Sloppiness, Experts Offer 5 Theories Why Aging Devices Are Recalled Most (Silver Sheet-$)
  • Animals in labs: PETA's long history with the medtech industry (Mass Device)
  • Feds call for HIT safety center (GovHealthIT)

In Focus: International

  • European Medicines Agency rejects Ombudsman's concerns on clinical data trial public access (Out-Law)
  • Merck, Endocyte Withdraw Marketing Applications For Ovarian Cancer Drug From EMA (WSJ-$) (Merck) (BioCentury)
  • Janssen Withdraws EU App for IV Administered Simponi (Press)
  • MHLW Japan Approves 14 New Drugs For NHI Listing (PharmAsia-$)
  • Canada Asked to Boost Supply of Generic OxyContin (CBC)

US: Pharmaceuticals/Biotechnology

  • The False Hope Of Colorado's 'Right To Try' Act (Forbes) (NBC)
  • CDER’s New Quality Office Still Awaiting Final Sign Offs (RPM Report-$)
  • FDA Power v. State Laws: Compounders Want Clarity On Office Use (Pink Sheet-$)
  • FDA Progress on the 2012 Drug Innovation Report by the President’s Council of Advisors on Science and Technology (FDA)
  • Merck’s Suvorexant Driving Claims May Get Green Light After Lunesta Re-Label (Pink Sheet-$)
  • PDS Releases First Publicly Available, FDA-Validated Dataset for SEND (Press)
  • Minnesota bans anti-bacterial chemical from soaps (AP)
  • Merck Animal Health Announces FDA Approval of BRAVECTO (fluralaner) (Press)
  • CDER's Rachel Sherman Joints Industry Consulting Group (Press)
  • NJ Bill Asks FDA to Reconsider Approval of Zohydro (Scout)
  • Qualification of cardiac troponins for nonclinical use: a regulatory perspective. (PubMed) (Oct 2013)
  • What you don't know about sunscreen could hurt you (CBS)

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

  • InterMune to refile IPF drug with FDA 'in weeks' (Pharma Times) (The Street) (Press) (Reuters)
  • GSK and Genmab reveal disappointing Ph III data with ofatumumab + chemo in B-cell lymphoma (Pharma Letter-$) (Pharma Times) (Press) (BioCentury)
  • FDA Grants QIDP Designation to Aradigm’s Inhaled Antibiotic (Press)
  • Karyopharm gets first of what it hopes to be several orphan designations (BioFlash) (Reuters)
  • Nordic Nanovector's Betalutin granted Orphan-drug Designation in the USA (Press)
  • Clovis Oncology Receives Breakthrough Therapy Designation for CO-1686 for the Treatment of Second-line EGFR Mutant Non-small Cell Lung Cancer (NSCLC) in Patients with the T790M Mutation (Press)
  • GSK Releases Positive Data on Safety, Efficacy of Incruse Ellipta for COPD (Press)

US: Pharmaceuticals and Biotechnology: General

  • The CIA says it will stop doing fake vaccination campaigns (Vox) (NYTimes) (CBS)
  • LEGGO the Logo? Why Pharma Logos Belong on CME (Hastings)
  • NECC, Tenn. Reach $5M Deal Over Meningitis Outbreak (Law 360-$)
  • Court: Execution Drug Maker a Secret in Georgia (AP)

US: Medical Devices

  • From Suppliers To Sloppiness, Experts Offer 5 Theories Why Aging Devices Are Recalled Most (Silver Sheet-$)
  • Animals in labs: PETA's long history with the medtech industry (Mass Device)
  • Feds call for HIT safety center (GovHealthIT)
  • FDA Panel Date Set For Bard’s Lutonix Drug-Coated Balloon (Gray Sheet-$)
  • AcuFocus gears up for FDA scrutiny on corneal implant (Fierce)
  • FDA approves Gauss Surgical’s app that turns iPads into real-time surgical blood loss monitors (MedCity News)
  • Assessment of cardiovascular and noncardiovascular medical device recalls (PubMed)
  • Registration Open for FDA's 3D Printing Workshop (FDA)
  • Proa Medical Receives 510(k) Clearance from FDA for Brella-Spec™ Vaginal Speculum for Gynecological and Obstetrical Procedures (Press)

US: Dietary Supplements

  • Why do many brand owners in the market interpret GMPs as stopping at the manufacturer’s door? (NI-USA)

US: Assorted And Government

  • PCORI Offers $90 Million in Second Call for Large Pragmatic Study Proposals (Press)
  • Obama Administration Health Agencies Accused Of Ethical Misconduct in Trials (Huffington Post) (The Hill)
  • The Roundtable Versus The Banquet Table (RPM Report-$)
  • The Importance of Post-Study Recruitment Reporting and Analyses (First Patient In)

Europe

  • European Medicines Agency rejects Ombudsman's concerns on clinical data trial public access (Out-Law)
  • Merck, Endocyte Withdraw Marketing Applications For Ovarian Cancer Drug From EMA (WSJ-$) (Merck) (BioCentury)
  • Janssen Withdraws EU App for IV Administered Simponi (Press)
  • An Interview With MHRA's Dr Ian Hudson (CSW)
  • BioControl Medical’s FitNeS Approved for Use in Europe as Adjunct Therapy for Treatment Resistant Depression (Press)

India

  • India’s Weak Patent Rights Hurt U.S. Pharma Companies (NCPA)
  • India Drug Makers Quick Off Mark To Lobby New Government On Issues (PharmAsia-$)

Japan & China

  • MHLW Japan Approves 14 New Drugs For NHI Listing (PharmAsia-$)

Other International

  • Canada Asked to Boost Supply of Generic OxyContin (CBC)
  • Merck to Give Skin Cancer Drugs to Sickest Patients for Free (IBT)

General Regulatory And Interesting Articles

  • Scientists foresee purer, safer drugs with help of 'twisted light' and nanotechnology (MNT)

Regulatory Reconnaissance #322 – 20 May 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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