Regulatory Focus™ > News Articles > Regulatory Recon: 23andMe Finds its Way Back Into FDA's Favor (20 February 2015)

Regulatory Recon: 23andMe Finds its Way Back Into FDA's Favor (20 February 2015)

Posted 20 February 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: 23andMe Finds its Way Back Into FDA's Favor (20 February 2015)

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

In Focus: US

  • In Big Shift, FDA Plans To Let 23andMe Market Genetic Tests To Consumers (FDA) (MedCityNews) (Forbes) (Forbes) (GenomeWeb) (Reuters) (Bloomberg) (23andMe)
  • FDA's Next-Gen Sequencing Oversight To Rely On 'Well-Curated' Databases (Gray Sheet-$)
  • Two New Studies Add to Scrutiny of Gynecology Tool (WSJ-$) (Fierce)
  • FDA knew devices spread fatal 'superbug' but does not order fix (Reuters)
  • GPhA, PhRMA To Tout Generic Labeling Alternative They Floated To FDA (IHP-$)
  • PASS Expects FDA’s Sunscreen Innovation Approach Will Surprise Capitol Hill (Tan Sheet-$)
  • Compounding Advisory Panel To Feature Bulk Voting On Bulk Substances (Pink Sheet-$)
  • Paying for gene therapy: are annuities the next big thing? (Reuters)

In Focus: International

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US: Pharmaceuticals and Biotechnology

  • GPhA, PhRMA To Tout Generic Labeling Alternative They Floated To FDA (IHP-$)
  • FDA Delay Shows Generics Label Critics Gaining Ground (Law 360-$)
  • FDA Provides Details on the Drug Compounding Draft Standard MOU (FDA Law Blog)
  • PASS Expects FDA’s Sunscreen Innovation Approach Will Surprise Capitol Hill (Tan Sheet-$)
  • Navigating the Affordable Care Act: Drug Sample Compliance (PCM)
  • Compounding Advisory Panel To Feature Bulk Voting On Bulk Substances (Pink Sheet-$)
  • Gay rights video mocks FDA blood proposal (Washington Times)
  • Authoring for eCTD – Know the Requirements and Think Like a Reviewer (Ask Cato)
  • Superbug Spread Reveals Thin Pipeline of Newest Antibiotics (Bloomberg)
  • Actavis Receives Final Approval for Generic Version of Subutex (Press)
  • Public Interest Groups Back NY AG In Namenda Appeal (Law 360-$)
  • Utah "Right to Try" Bill Advances (SLTribune)
  • New Right to Try Bill Filed in Florida (Sunshine State News)

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

  • Flu Treatment Sponsored By DoD's Medical Countermeasure Systems Takes Major Step Forward In Clinical Trials (Press)

US: Pharmaceuticals and Biotechnology: General

  • Paying for gene therapy: are annuities the next big thing? (Reuters)
  • New rules on narcotic painkillers cause grief for veterans and VA (WaPo)
  • A biological quest leads to a new kind of breast cancer drug (NPR)
  • VaxInnate reaps $53M for flu jab trials on BARDA contract extension (Fierce)
  • IDRI receives $4m from BARDA to create adjuvant manufacturing hub (BiopharmaReporter)

US: Medical Devices

  • In Big Shift, FDA Plans To Let 23andMe Market Genetic Tests To Consumers (FDA) (MedCityNews) (Forbes) (Forbes) (GenomeWeb) (Reuters) (Bloomberg) (23andMe)
  • FDA's Next-Gen Sequencing Oversight To Rely On 'Well-Curated' Databases (Gray Sheet-$)
  • Two New Studies Add to Scrutiny of Gynecology Tool (WSJ-$) (Fierce)
  • FDA knew devices spread fatal 'superbug' but does not order fix (Reuters)
  • UCLA Superbug Outbreak: How Endoscopes Got Dirty (NBC)
  • Medtronic And Boston Scientific Plan To Resume Blood Pressure Trials This Year (Forbes)
  • GE recalls 10,000+ MRI systems after FDA deems them potentially deadly, citing poor training (Fierce)
  • 6 Ways to Ensure Your QMS Meets FDA and ISO Compliance (GxP Lifeline)
  • FDA panel to consider PMA application of spinal implant (Fierce)
  • Go For De Novo: FDA’s Revised Approach to Medical Device Accessories (National Law Review)
  • FDA clears Dallen's Tensyn Plug (Mass Device)
  • Study Shows Medtronic Deep Brain Stimulation Therapy for Treatment-Resistant Epilepsy Demonstrates Significant and Sustained Seizure Reduction at Five Years (Press)
  • Wearable insulin delivery device shown effective in trial for three-day use (Fierce)

US: Dietary Supplements

  • CRN outlines industry impact in enforcing 'rigid' substantiation standard (DSN)
  • What It Means To Be in Compliance with USP’s Standards for Herbal Supplements (USP)

Upcoming Meetings

Ebola Outbreak

  • WHO approves breakthrough 15-minute Ebola test (Reuters)
  • Limited airborne transmission of Ebola is ‘very likely,’ new analysis says (WaPo)

Europe

  • Europe approves Western world's first stem-cell therapy for rare eye condition (Reuters)
  • EU stakeholders form medicines traceability organization (PharmaPhorum) (EMA)
  • NICE drafts yeses for competing DME drugs Eylea and Ozurdex (SCRIP-$) (PharmaTimes) (PharmaLetter-$) (PharmaLetter-$) (Pink Sheet-$) (PMLive)
  • Boehringer in ABPI Code breach over beer drinking, lederhosen presentation (PMLive)
  • European Industry Objects to Disclosure of Trial Information (FDAnews-$) (EFPIA)
  • Celltrion Touts Savings Potential of Biosimilars (Press)
  • REVLIMID (Lenalidomide) Approved by the European Commission for the Treatment of Adult Patients with Previously Untreated Multiple Myeloma who are Not Eligible for Transplant (Press)
  • Gilead agrees to Sovaldi price cuts in Germany (BioCentury)
  • IQWiG says Octapharma provided no suitable data on Nuwiq to show added benefit (PharmaLetter-$)
  • Data From One of Europe's Largest Independent Liver Transplant Registries Reveals Improved Graft Survival Benefit in Patients Receiving Advagraf Prolonged Release Tacrolimus Compared to Those on Tacrolimus Immediate Release (Press)

India

China

Canada

  • Citronella bug spray makes comeback after public pressure (CBC)
  • First Proton Therapy Device Cleared in Canada (Medscape)

General Regulatory And Interesting Articles

  • The World Could Be On The Verge Of Losing A Powerful Malaria Drug (NPR) (NYTimes)

Regulatory Reconnaissance #498 – 20 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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