Regulatory Focus™ > News Articles > Regulatory Recon: FDA Loses Major Case Testing Device Reclassification Authority (29 September 2014)

Regulatory Recon: FDA Loses Major Case Testing Device Reclassification Authority (29 September 2014)

Posted 29 September 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Loses Major Case Testing Device Reclassification Authority (29 September 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s  2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.   Register here, or check out some of the most news-worthy sessions here.

In Focus: US

  • FDA Loses Major Case Regarding Authority to Reclassify Medical Devices (Scout) (FDA Law Blog) (Policy and Medicine)
  • FDA approves Alimera’s Iluvien for DME (BioCentury) (Reuters) (Press) (Press)
  • FDA Oncology Review Times Far Better Than Those at EMA, Health Canada (Pharma Times) (CTV)
  • FDA says asthma drug Xolair raises risk of heart, brain problems (Reuters) (FDA)
  • FDA Weighs Offering Tentative Biosimilar Approvals, Grapples With Exclusivity (IHP-$)
  • 1st Amendment Looms Large Over FDA's Twitter Rules (Law 360-$)
  • Guidance Outlining Up to 10 Quality Metrics Expected by Year’s End: FDA Official (FDA News-$)
  • Stimulated Reporting: The Impact FDA-Issued Alerts on FAERS (PubMed)
  • Roche Breast Cancer Drug Perjeta Appears to Greatly Extend Patients’ Lives (NYTimes) (Reuters) (Press) (Guardian)
  • FDA Researchers Look into Statistical Consideration of Patient-Reported Outcomes (PubMed)
  • FDA’s $300M Biodefense Complex Opens (Gazette)

In Focus: International

  • India Now Requires all Medical Devices to be Labeled (PharmaBiz)
  • EFPIA considering infringement suit over Italian off-label law (SCRIP-$)
  • India mulls legal action against US think tank's 'smear' campaign (SCRIP-$) (India Times) (S4S Response)
  • Scientists grapple with ethics in rush to release Ebola vaccines (Reuters)
  • EMA Opens Investigation into India’s GVK Bio Over ECG Falsifications (Outsourcing Pharma)
  • India Wants Storage Information to be Included on Drug Labels (PharmaBiz)
  • China regulator set to allow prescription medicine to be sold on Internet (People’s Daily)
  • WHO sees small-scale use of experimental Ebola vaccines in January (Reuters)

US: Pharmaceuticals and Biotechnology

  • FDA approves Alimera’s Iluvien for DME (BioCentury) (Reuters) (Press) (Press)
  • FDA Oncology Review Times Far Better Than Those at EMA, Health Canada (Pharma Times)
  • FDA says asthma drug Xolair raises risk of heart, brain problems (Reuters) (FDA)
  • FDA Weighs Offering Tentative Biosimilar Approvals, Grapples With Exclusivity (IHP-$)
  • 1st Amendment Looms Large Over FDA's Twitter Rules (Law 360-$)
  • The Biopharmaceutics Risk Assessment Roadmap for Optimizing Clinical Drug Product Performance (PubMed)
  • Guidance Outlining Up to 10 Quality Metrics Expected by Year’s End: FDA Official (FDA News-$)
  • At White House, Prescription Drug Protesters Call for New FDA Chief (ABC)
  • Continuing Resolution Allows FDA To Collect Drug Compounding Fees (IHP-$)
  • Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS) (PubMed)
  • Measures to quantify the abuse of prescription opioids: a review of data sources and metrics (PubMed)
  • Will The FDA Delay The DSCSA? No, And Here’s Why (RxTrace)
  • Despite FDA Warning, No OSP-Acute Kidney Injury Risk Link Seen in New Study (MPR)
  • Alkermes Prodrug for Treatment of Multiple Sclerosis: NCE? (Camargo)
  • How Smoking Cessation Could Affect Warfarin Treatment (MPR)
  • FDA Wants to Let Pharma Edit Wikipedia Articles. Will Wikipedia Let Them? (Pharma Marketing Blog)
  • Male 'Enhancement' Drugs Called Dangerous Amid FDA Crackdown (NBC)
  • Actavis files ANDA for generic of Purdue's Butrans (Pharma letter-$)

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

  • Roche Breast Cancer Drug Perjeta Appears to Greatly Extend Patients’ Lives (NYTimes) (Reuters) (Press) (Guardian)
  • BMS's Opdivo gets Priority Review (BioCentury) (Reuters) (Press) (SCRIP-$)
  • Bristol immune drug Opdivo shows strong effect in melanoma study (Reuters) (Press)
  • Repros gains on second Androxal Phase III (BioCentury)
  • Bausch + Lomb Receives Successful Results from Phase 3 Study (Press)
  • BI’s Afatinib Has Positive Showing in PhIII Trials in Squamous Cell Carcinoma (Press)
  • Genentech’s Investigational Combination of Cobimetinib Plus Zelboraf (Vemurafenib) Provided Significant Benefit to People With Advanced Melanoma Over Zelboraf Alone (Press)
  • Acura’s Generic Abuse-Resistant Drug Meets Endpoints (Press)
  • Seattle Genetics, Takeda's cancer drug meets main goal in trial (Reuters) (Press)
  • Gain from adding Roche's Avastin to immune drug unclear (Reuters)
  • Puma Biotechnology cancer drug shows positive mid-stage results (Reuters) (Press)
  • Tonix Pharma's pain drug fails mid-stage study (Reuters)
  • Cancer Wasting Drug Succeeds in PhIII Trial (Press)
  • Exelixis Announces Positive Results from Phase 3 Pivotal Trial of Cobimetinib in Combination with Vemurafenib in Patients with BRAF V600 Mutation-Positive Advanced Melanoma (Press)
  • No benefit from continued use of AstraZeneca's Iressa drug (Reuters)
  • GlycoMimetics down on Phase III delay (BioCentury)
  • CytRx Gets Multiple Orphan Drug Designations For Aldoxorubicin (Press)
  • FDA Grants Orphan Drug Status To Insys' Brain Tumor Treatment (RTT)
  • Merck immunotherapy drug shows promise in bladder cancer (Reuters) (Press)
  • Pfizer drug effective in patients with rare lung cancer: study (Reuters)
  • Merck drug extends immune system fight to stomach cancer (Reuters)
  • Rolapitant reduces nausea and vomiting in Phase III trial (Press)
  • Transgene Presents Additional Positive Clinical Data from Phase 2b Part of TIME Trial with TG4010 at ESMO (Press)

US: Pharmaceuticals and Biotechnology: General

  • SCRIP’s US Capitol Capsule: Ebola crisis spurs vows to boost global health security (SCRIP-$)
  • Narrowing Part D Protected Classes Won’t Be Proposed Again – Tavenner (Pink Sheet-$)
  • Patient Advocates Enlist Senate In Fighting TPP Drug Pricing Provisions (IHP-$)

US: Medical Devices

  • FDA Loses Major Case Regarding Authority to Reclassify Medical Devices (Scout) (FDA Law Blog) (Policy and Medicine)
  • Methodological Considerations in Observational Comparative Effectiveness Research for Implantable Medical Devices: An Epidemiologic Perspective (PubMed)
  • FDA Says It Will Accept International Standard On Fluoroscopic Equipment (Gray Sheet-$)
  • Tech Tweaks to Get More Info From Medical Devices (WSJ-$)
  • Clinical Evaluation of New Heart Valve Prostheses: Update of Objective Performance Criteria (PubMed)
  • DOD awards $67M in contracts to Zoll, Philips (Fierce)
  • Former AdvaMed board chair accused of insider trading (Fierce)
  • Crospon Receives Expanded Indications from FDA for EsoFLIP Dilation Catheter (Press)

US: Assorted And Government

  • FDA Researchers Look into Statistical Consideration of Patient-Reported Outcomes (PubMed)
  • FDA’s $300M Biodefense Complex Opens (Gazette)
  • Being Blunt About Product Safety: The problems with the lack of uniformity in medical marijuana laws (Harvard BOH)
  • GOP bets on regulations backlash (The Hill) (The Hill)
  • Are there too many regulations? (The Hill)

Upcoming Meetings

Ebola Outbreak

  • WHO sees small-scale use of experimental Ebola vaccines in January (Reuters)
  • Scientists grapple with ethics in rush to release Ebola vaccines (Reuters)
  • U.S. says diseases like Ebola should be viewed as security threats (Reuters)
  • The Ebola leadership gap (Politico)
  • How Is Fujifilm Helping In The Fight Against Ebola? (NPR)
  • U.S. Troops Battling Ebola Get Off to Slow Start in Africa (WSJ-$)

Europe

  • EMA Opens Investigation into India’s GVK Bio Over ECG Falsifications (Outsourcing Pharma)
  • EFPIA considering infringement suit over Italian off-label law (SCRIP-$)
  • EMA final guidelines for IBS trials (BioCentury)
  • Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan (EC)
  • EDQM Updates Certificate of Suitability Forms (EDQM)
  • The price is right: drug reimbursement in Europe (PMLive)
  • UK Postpones Decision on Value-Based Assessment — Again (PharmExec)
  • Negotiations on EU-Canada Free Trade Agreement concluded (Pharma Letter-$)
  • ReFlow Medical wins CE Mark for crossing catheters (Mass Device)

India

  • India Now Requires all Medical Devices to be Labeled (PharmaBiz)
  • India Wants Storage Information to be Included on Drug Labels (PharmaBiz)
  • India mulls legal action against US think tank's 'smear' campaign (SCRIP-$) (India Times) (S4S Response)
  • PM Narendra Modi forced NPPA to relax essential drugs norms: Congress (India Times)
  • Government study on spurious drugs to gain momentum (Hindu Business Line)

China

  • China regulator set to allow prescription medicine to be sold on Internet (People’s Daily)
  • China Policy: Parents Donate Blood, Kids get Extra Points in School (Marginal Revolution)
  • CFDA: All Chinese aphrodisiacs are useless (ECNS)
  • Elekta Says China FDA Clears Versa HD Linear Accelerator For Sale, Marketing (RTT)

Japan

  • Japan approves pegfilgrastim for neutropenia (BioCentury)

Canada

  • Cancer drug approvals: Canada often takes longer than U.S. (CTV)

Australia

  • Meningitis Vaccine Recalled in Australia Due to Potential Contamination (TGA)

Other International

Clinical Trials

  • Lung cancer clinical trials: Lung-MAP and ALCHEMIST, the first "Master Protocol" trials (MNT)

General Regulatory and Interesting Articles

  • Hundreds of firms join global hunt for biosimilars (Reuters)
  • Failed cancer vaccines might live again with new immune drugs (Reuters)

Regulatory Reconnaissance #409 – 29 September 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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