Regulatory Focus™ > News Articles > Regulatory Recon: FDA's Progress on Mobile Health Leaves Congress Wanting More (12 February 2015)

Regulatory Recon: FDA's Progress on Mobile Health Leaves Congress Wanting More (12 February 2015)

Posted 12 February 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA's Progress on Mobile Health Leaves Congress Wanting More (12 February 2015)

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

In Focus: US

  • Despite FDA moves, push continues for Congress to act on mobile health (Politico)
  • US healthcare groups recommend ways of tackling ongoing drug shortages (PharmJournal) (Fierce)
  • Women on Accutane need better contraceptive knowledge (Reuters)
  • FDA Soft Sells GMP Quality Overhaul For Generics; Don’t Be ‘Anxious,’ Woodcock Says (Pink Sheet-$) (IHP-$)
  • A Novel bioequivalence approach for narrow therapeutic index drugs (PubMed)
  • CDRH Appoints Public Health Expert To Lead Postmarket Surveillance Reform (Gray Sheet-$)
  • Chains Pull Dietary Aids Off Shelves After Inquiry (NYTimes) (Bloomberg)
  • A Conversation with FDA Commissioner Dr. Margaret Hamburg (FOCR)

In Focus: International

  • MHRA Warns of People Impersonating its Staff (MHRA)
  • Italy's off-label rule "turns EU system upside down", says EFPIA's Bergström (SCRIP-$)
  • Tear up the rules and start again, Lancet panel says to India on drug safety (Fierce)
  • Chinese pharmacies preparing for online sales of pharamceuticals (DSN)

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US: Pharmaceuticals and Biotechnology

  • US healthcare groups recommend ways of tackling ongoing drug shortages (PharmJournal) (Fierce)
  • Women on Accutane need better contraceptive knowledge (Reuters)
  • FDA Soft Sells GMP Quality Overhaul For Generics; Don’t Be ‘Anxious,’ Woodcock Says (Pink Sheet-$) (IHP-$)
  • FDA Advisory Committee to Review Merck’s Bridion for Selective Reversal of Neuromuscular Blockage (Tarius)
  • Another Recall for Hospira, Which Recalls Injectable Drug Over Particulates (FDA) (FDA)
  • Teva Probe Reveals 'Likely' FCPA Transgressions (Law 360-$)
  • Novel bioequivalence approach for narrow therapeutic index drugs (PubMed)
  • AstraZeneca Settles Nexium Kickback Suit; Deals Prohibiting Authorized Generic Sales Alleged (Pink Sheet-$)
  • Racial/ethnic differences in drug disposition and response: Review of recently approved drugs (PubMed)
  • Regulatory shakeup needed to fight antimicrobial resistance, says PwC report (PharmaLetter-$)
  • Trial geography, pharmacogenetics, and global drug development (PubMed)
  • Another doctor convicted for selling foreign-made drugs (Fierce)

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

  • Anika Therapeutics Announces Regulatory Submissions with U.S. FDA and European Regulatory Authorities for Cingal (Press)
  • Eisai Says FDA Approval for its Anticancer Drug Lenvatinib "Imminent" (WSJ-$) (Press)
  • Motor neurone disease patients push US to fast-track promising new drug (Guardian)
  • Genzyme Presents Phase 3 Clinical Trial Extension Results for Cerdelga (eliglustat) (Press)
  • Verastem Receives Orphan Drug Designation from FDA for VS-5584 in Mesothelioma (Press)
  • NanoSmart Receives FDA Orphan Drug Designation for ANA-Conjugated Liposomal Doxorubicin for the Treatment of Ewing's Sarcoma (Press)

US: Pharmaceuticals and Biotechnology: General

  • New York, New England groundwater teeming with pharmaceuticals (CBS)
  • Why isn’t there more mental health drug innovation? (Healthcare Economist)
  • Health Insurance Exchange Plans Increasingly Putting Needed Medicines Out of Reach (PhRMA)

US: Medical Devices

  • First custom device annual report due March 31, 2015 (Hogan Lovells)
  • Despite FDA moves, push continues for Congress to act on mobile health (Politico)
  • CDRH Appoints Public Health Expert To Lead Postmarket Surveillance Reform (Gray Sheet-$)
  • AdvaMedDx: Inclusion Of LDTs In Cures Bill Uncertain, Depends On Stakeholder Engagement (IHP-$)
  • A New Guide to Help Hospitals Track Medical Devices (Pew)
  • Clot Extractors Shown Beneficial In Stroke Patients (Forbes) (Reuters)
  • Experts: 2015 could be 'Year of the Healthcare Hack' (Mass Device)
  • Titan Spine Receives FDA Clearance to Launch Endoskeleton® TCS Device for Cervical Fusion with Integrated Fixation (Press)
  • Amedica Submits 510(k) Application to FDA for Composite Spinal Interbody Spacers With Porous Silicon Nitride Center (Press)

US: Dietary Supplements

  • Chains Pull Dietary Aids Off Shelves After Inquiry (NYTimes) (Bloomberg)
  • Knowing What’s in Your Supplements (NYTimes)
  • CRN sends formal request to NY AG to release the report, rolls out website info center (NI-USA)

US: Assorted And Government

  • A Conversation with FDA Commissioner Dr. Margaret Hamburg (FOCR)
  • DeGette Says Obama Wants To Engage On Cures Initiative, Explains Not Endorsing Draft Bill (IHP-$)
  • U.S. Challenges Chinese Export Program (PharmPro) (Law 360-$)
  • NIH convenes Precision Medicine meeting (BioCentury) (SCRIP-$)

Upcoming Meetings

Ebola Outbreak

  • Novavax starts Ebola vaccine trial in humans (Reuters)
  • Withdrawing Troops, Obama Calls for Vigilance on Ebola (NYTimes)

Europe

  • MHRA Warns of People Impersonating its Staff (MHRA)
  • Italy's off-label rule "turns EU system upside down", says EFPIA's Bergström (SCRIP-$)
  • Websites selling illegal drugs increasingly face closure (Pharmafile)
  • EU GMP Annex 1: EMA plans the Revision of the Sterile Guide (ECA)
  • Accessibility to suitable and age-appropriate unlicensed medicines for children: the “PaedForm” project (EDQM)
  • CMDh Position Paper on QR Codes Published (ECA)
  • Baxter plans to file long-acting Advate in EU next year (PMLIve)
  • Gilead agrees 41,000 euro hep-C drug price for 12 week treatment (Reuters)

India

  • Tear up the rules and start again, Lancet panel says to India on drug safety (Fierce)
  • Big Pharma groupings urges US to ask India to change its IPR policies (India Times)
  • Biogen Idec gets DCGI nod for multiple sclerosis oral drug (India Times)

China

  • Chinese pharmacies preparing for online sales of pharamceuticals (DSN)

Japan

Canada

  • 'We failed.' Toronto Star publisher says the paper's HPV vaccine article 'let down' readers (CBC)

Australia

  • Australia to Convene Vaccine Safety Committee (TGA)
  • TGA Warning on Zenith Alpha thoracic endovascular graft (TGA)
  • Medicines Australia makes submission to the 2015-2016 federal budget (PharmaLetter-$)

Clinical Trials

  • Sanofi backs fully remote clinical trial for diabetes management (MobiHealthNews)

General Regulatory And Interesting Articles

  • Does a Real Anti-Aging Pill Already Exist? Inside Novartis’s push to produce the first legitimate anti-aging drug (Bloomberg)
  • ViiV tops reputation survey as Gilead tumbles (PharmaPhorum)
  • Big condoms partly to blame for Thai teen STI spike: ministry (AFP)

Regulatory Reconnaissance #492 – 12 February 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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