Regulatory Focus™ > News Articles > Regulatory Recon: Obama, FDA Working on Rethink of Genetic Testing Regulation (2 February 2015)

Regulatory Recon: Obama, FDA Working on Rethink of Genetic Testing Regulation (2 February 2015)

Posted 02 February 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Obama, FDA Working on Rethink of Genetic Testing Regulation (2 February 2015)

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

In Focus: US

In Focus: International

  • New Outsourcing Frontier in India: Monitoring Drug Safety (WSJ-$)
  • India: Centre approves 25 panels of experts for SECs for evaluation of applications of clinical trials, new drugs & devices (PharmaBiz)
  • India: Non-compliance 'pattern' at Zydus site stokes concern (SCRIP-$)
  • India: AIDCOC objects to Centre's proposal in draft Bill 2015 to centralise licensing system (PharmaBiz)
  • EU: Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus (EMA)
  • Xiapex approved by the EU Commission for the treatment of Peyronie's disease (Press)

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US: Pharmaceuticals and Biotechnology

  • FDA approves Vyvanse for binge-eating disorder (BioCentury) (PharmaTimes) (Press) (FDA) (Pharmafile) (SCRIP-$)
  • FY 2015 First Quarter OGD Stats are Published – Picture is Not Rosy (Lachman)
  • Abuse-Deterrent Zohydro OK'd (MedPage Today) (Press) (SCRIP-$)
  • FDA Estimates it Will Take as Long to Fill Out Biosimilar 351(k) as a BLA (FDA)
  • New Outsourcing Frontier in India: Monitoring Drug Safety (WSJ-$)
  • Illinois may become sixth state with 'right-to-try' law (Modern Healthcare)
  • FDA Accused Of Helping J&J Cover Up Risperdal Data (Law 360-$)
  • Risperdal Judge Warns J&J Over Introducing FDA Docs (Law 360-$)
  • FDA approves Novartis eye drops Pazeo (PharmaTimes) (Press)
  • FDA Explains How It Counts To 30 Months (Pink Sheet-$)
  • Bipartisan No More: Top Dems Denounce Draft Biomedical Reform Legislation (Pink Sheet-$)
  • Learning To Drive The ‘Chariot’: FDA Deputy Califf’s New Role (Pink Sheet-$)
  • Califf’s Trial Design Prescription: Less Randomization, More Transparency (Pink Sheet-$)
  • FDA’s investigation into patients being injected with simulated IV fluids continues (FDA)
  • BIO: Congress Under-Funding Medical Countermeasure Development (BIO)
  • BIO Pans Warren's Medical Innovation Act (BIO)
  • FDA Clears Way for Generic Effexor, Other Drugs (FDA)
  • Adverse events following measles, mumps, and rubella vaccine in adults reported to the Vaccine Adverse Event Reporting System (VAERS), 2003-2013 (PubMed)
  • U.S. FDA approves first-in-class Glyxambi (empagliflozin/linagliptin) tablets for adults with type 2 diabetes (Press)
  • FDA Approves New Dosing Option for CSL Behring's Hizentra (Press)
  • Patient-Focused Drug Development: To Understand Patients, You Must Engage Them (LifeSciLeader)
  • Arizona court: Patients can sue pharmaceuticals for fraud (Tuscon)
  • CDER names Shreeve communications director (BioCentury)

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

  • Repros Submits New Drug Application to FDA for Androxal (Press)
  • Gene therapy pioneer bluebird bags a 'breakthrough' title for lead program (Fierce) (Press)
  • FDA fast-tracks Roche lung cancer drug (Press)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Obama: Working With FDA "To Develop New Approaches" to Evaluate Genetic Tests (White House) (WH) (FDA) (AdvaMed)
  • Obama Precision Medicine Fuels Fire Over FDA's Plan For LDTs (IHP-$)
  • AMP Submits Written Comments to FDA on Proposed Regulation of Laboratory Developed Tests (Press)
  • Scarcity Of Quality/Regulatory Experts: A Call To Action For Educators (Gray Sheet-$)
  • Not APPY: Venaxis stock plunges on new FDA no for appendicitis test (Clinica-$)
  • Stomach-draining obesity startup gets $12M in debt to support PMA in mid-2015 (Fierce)
  • The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database. (PubMed)
  • DePuy Synthes Spine wins expanded approval for Synapse spinal device (Mass Device)
  • Latest Device for In-Home Hair Restoration Technology Cleared by FDA (Press)
  • IRIDEX Receives FDA Clearance for Cyclo G6™ Laser System for the Treatment of Multiple Stages of Glaucoma (Press)
  • MedShape Announces FDA Clearance of New 3D Printed Titanium Bone Tether Plate that Preserves Bone Anatomy (Press)

US: Dietary Supplements

  • Court Upholds FTC Order Against POM, But Scrutinizes Clinical Trial Requirement (Tan Sheet-$) (DC Court) (NI-USA) (Reuters) (FDA Law Blog)
  • DeLauro, Durbin Reheat Proposal For Separate Food Safety Agency (Tan Sheet-$)
  • United States enters consent decree prohibiting illegal distribution of Luvena Prebiotic products (FDA)
  • Are Vitamin Drinks a Bad Idea? (NYTimes)

US: Assorted And Government

  • FTC Releases New Labeling Regulation (FTC)
  • Parsing the President’s Budget for FDA: Learnings to Date (Strengthen FDA) (Morning Consult)
  • House eyes tighter rules for reporting cost of regs (The Hill)
  • Enforcement Report - Week of January 28, 2015 (FDA)
  • CDC Urges Measles Vaccinations amid Disneyland Outbreak (Reuters)

Upcoming Meetings

Ebola Outbreak

Europe

  • Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus (EMA)
  • Reflection paper on the risk of antimicrobial resistance transfer from companion animals (EMA)
  • Guideline on risk characterisation and assessment of maximum residue limits (MRL) for biocides (EMA)
  • Xiapex approved by the EU Commission for the treatment of Peyronie's disease (Press)
  • Soliris first drug recommended through NICE's specialised tech unit (Biopharma Reporter)
  • Medtronic Expands Access to the Next Generation CoreValve Evolut R System with New Valve Sizes (Press)
  • Summary Report of European Commission’s mHealth Consultation Published (Inside Medical Devices)
  • International campaigners urge UK to allow 'three-parent' IVF babies (Reuters)
  • Enlivex Granted EU Orphan Drug Designation for Lead Product ApoCell for Graft-Versus-Host Disease (Press)
  • Rising UK drugs bill raises fears of price controls (PharmaPhorum)

India

  • Non-compliance 'pattern' at Zydus site stokes concern (SCRIP-$)
  • AIDCOC objects to Centre's proposal in draft Bill 2015 to centralise licensing system (PharmaBiz)
  • Centre approves 25 panels of experts for SECs for evaluation of applications of clinical trials, new drugs & devices (PharmaBiz)
  • Insight On India – Highlights From The Week Of Jan 25-31, 2015 (Two-Four Insight)
  • IPA demands setting up of Dept of FDA under health ministry for better implementation of food & drugs laws (PharmaBiz)
  • Centre to augment compliance of India pharma with recent slew of regulations: Dr BR Jagashetty (PharmaBiz)

Australia

  • Australia Warns on Counterfeit Cialis (TGA)

Clinical Trials

  • Astellas Broadens Commitment To Clinical Trial Data Transparency (Press)
  • IOM and Congress Press On to Expand Clinical Trials Data Sharing, Despite Ongoing NIH Rulemaking (FDA Law Blog)

General Regulatory And Interesting Articles

  • Underpowered And Overinterpreted (In the Pipeline)
  • 1 in 5 millennials thinks vaccines cause autism (Vox)
  • Measles Is A Killer: It Took 145,000 Lives Worldwide Last Year (NPR)
  • "Father of birth control pill" dies (CBS)
  • MSF: We want vaccines for a fair price, not free (Guardian)

Regulatory Reconnaissance #484 – 2 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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