Regulatory Focus™ > News Articles > Regulatory Recon: EU Moving Ahead With Proposed Medical Device Reforms (16 June 2015)

Regulatory Recon: EU Moving Ahead With Proposed Medical Device Reforms (16 June 2015)

Posted 16 June 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: EU Moving Ahead With Proposed Medical Device Reforms (16 June 2015)

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

In Focus: US

  • 21st Century Cures Act Will Likely See a Vote in the House by End of June (Politico)
  • CIA torture appears to have broken spy agency rule on human experimentation (Guardian)
  • GDUFA II: Facility Fees Might Be Deferred Until ANDA Approval (Pink Sheet-$)
  • Should Non-Patent Exclusivity be Conditioned on Launch Price? One Scholar Puts Forth "A Modest Proposal" (FDA Law Blog)
  • Gilead gets whistleblower case over AIDS drug tossed (Reuters)
  • Veterinary Groups Decry FDA's Recent Animal Drug Compounding Guidance (Press)
  • FDA to hand over Preventing Surgical Fires Initiative to The Joint Commission (Fierce)
  • Mobile Apps: To be, or not to be, regulated by the FDA (mHealthNews)

In Focus: International

  • EU Moving Ahead With Proposed Medical Device Reforms (MDL) (Politico)
  • Early dialogue to support development of medicines for children (EMA)
  • Deadline nears on EU logo for online pharmacies (Securing Industry)
  • New mandatory logo for selling medicines online (MHRA) (MHRA)
  • China Looks For GMP Gaps As It Preps For PIC/S Application (PharmAsia-$)

US: Pharmaceuticals and Biotechnology

  • GDUFA II: Facility Fees Might Be Deferred Until ANDA Approval (Pink Sheet-$)
  • Should Non-Patent Exclusivity be Conditioned on Launch Price? One Scholar Puts Forth "A Modest Proposal" (FDA Law Blog)
  • Gilead gets whistleblower case over AIDS drug tossed (Reuters)
  • Veterinary Groups Decry FDA's Recent Animal Drug Compounding Guidance (Press)
  • FDA REMS Reforms Lacking Patient Engagement So Far (Pink Sheet-$)
  • FDA alerts health care providers, researchers and patients not to use certain products from ScienceLab.com (FDA)
  • Experts urge FDA to step in to quash 'Low-T' awareness efforts (Fierce)
  • Rhode Island House Passes Right to Try Bill (Press)
  • Zegerid OTC, Private Label Omeprazole Add Drug Interaction Warnings (Tan Sheet-$)
  • FDA Approves ZOMIG® (zolmitriptan) Nasal Spray for Migraine in Pediatric Patients (Press)

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

  • AZ's phase III gout data frustrates firm (PMLive) (SCRIP-$) (Fierce)
  • RedHill's antibiotic meets Phase III endpoint (BioCentury) (Fierce)
  • Richter And Allergan Announce FDA Has Extended The Review Period For Cariprazine To September 2015 (Press)
  • Data looking better for CTI's blood cancer drug tosedostat (SCRIP-$)
  • Avalanche eye therapy meets safety goal; vision improvement modest (Reuters) (The Street)
  • Aerie Pharmaceuticals Receives Positive Feedback from FDA (Press)
  • Advaxis Submits Special Protocol Assessment Request to FDA for ADXS-HPV Phase 3 Clinical Trial in Cervical Cancer (Press)
  • Protalex Receives Orphan Drug Designation from FDA for PRTX-100 to Treat Immune Thrombocytopenia (Press)

US: Pharmaceuticals and Biotechnology: General

  • ​Most Americans Say Drug Costs Are 'Unreasonable,' Although They Can Still Afford To Buy Them (KHN) (CNBC)
  • Bill Clinton slams high prices of biotech drugs (BioSpectrum)
  • The top 10 most-advertised prescription drug brands (Fierce)
  • New Study: Policy Environment Has a Significant Impact on Biopharmaceutical Investment (PhRMA)

US: Medical Devices

  • FDA to hand over Preventing Surgical Fires Initiative to The Joint Commission (Fierce)
  • Mobile Apps: To be, or not to be, regulated by the FDA (mHealthNews)
  • B. Braun's Aesculap wins FDA nod for lumbar disc (MassDevice) (Press)
  • FH Ortho Receives FDA 510(k) Clearance for Its CALCAnail Orthopedic Arthrodesis Nail (Press)
  • Micro-cap Accurexa gains on FDA submission for brain therapeutic delivery device (Fierce)

US: Assorted And Government

  • CIA torture appears to have broken spy agency rule on human experimentation (Guardian)
  • 21st Century Cures Act Will Likely See a Vote in the House by End of June (Politico)
  • Workers Can Be Fired for Marijuana Use, Colorado Court Rules (NYTimes)

Upcoming Meetings and Events

Europe

  • The Council's IVD regulation proposal for the general approach (MDL) (Politico)
  • Early dialogue to support development of medicines for children (EMA)
  • Deadline nears on EU logo for online pharmacies (Securing Industry)
  • New mandatory logo for selling medicines online (MHRA) (MHRA)
  • Data Transparency Initiatives Could Deter Industry Investment, Attorney Says (Pink Sheet-$)
  • Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases (EMA)
  • Morning-after pill now available to girls under 16 in the UK (Telegraph) (HuffPo)
  • Ireland mulls EU complaint over Alexion's stance on Soliris price (SCRIP-$)

China

  • China Looks For GMP Gaps As It Preps For PIC/S Application (PharmAsia-$)

Japan

  • Japan's PAFSC backs Lilly's dulaglutide, among others, in latest round (Fierce)

Canada

Clinical Trials

  • CIA torture appears to have broken spy agency rule on human experimentation (Guardian)
  • Can You Test A Drug And Also Say Negative Things About It? (CardioBrief)

Other International

  • Kenya's Lab Intensifies Fight against Poor Quality Medicines (USP)
  • Peruvian Regulators Place New Requirements on Medical Devices with PVC Components (Emergo)

General Regulatory And Interesting Articles

  • Do medical marijuana laws increase teen pot smoking? No (CBS)
  • Why buying drugs online is safer than buying them on the street (WaPo)

Regulatory Reconnaissance #576 – 16 June 2015

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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