Regulatory Focus™ > News Articles > Regulatory Recon: FDA a Core Component of Obama Push on Personalized Medicine (30 January 2015)

Regulatory Recon: FDA a Core Component of Obama Push on Personalized Medicine (30 January 2015)

Posted 30 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA a Core Component of Obama Push on Personalized Medicine (30 January 2015)

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

In Focus: US

  • Senate Republicans seek reforms for NIH, FDA (BioCentury) (Report)
  • Obama Wants $10M for FDA to Help Regulate Precision Medicine (NYTimes) (MIT) (Reuters) (SCRIP-$) (Modern Healthcare-$)  (WaPo)
  • FDA OK's 2 HIV drugs: BMS' Evotaz, J&J's Prezcobix (SCRIP-$) (Pharmafile) (Janssen PR) (BMS PR)
  • Pharmacyclics/Janssen win FDA OK for Imbruvica in Waldenstrom's (SCRIP-$) (Press) (BioCentury) (FDA) (Reuters)
  • Sen. Warren Introduces Medical Innovation Act to Increase Federal Investments in Research (Warren)
  • Minimal Manipulation: Two draft guidances indicate FDA may expand the scope of HCT/P products subject to premarket review (Lexology)
  • U.S. Still Pushing for 12-Years Biologics Patent Protection Under TPP (FDAnews-$)
  • CDRH Accounting for Patient Preferencess in Regulatory Approvals Process (FDA) (RTI)
  • FDA Announces Lengthy Extension on Comment Period for its "Red Book" Revisions (FDA)

In Focus: International

  • EU report provides basis for effective fight against development of resistant bacteria (EMA)
  • 50 Years of EU Pharmaceutical Legislation in the EU (EC)
  • Patient Groups Raise Ante Against Gilead’s India Deals (PharmAsia-$)
  • India warns drugmakers failure not an option for price data due next week (Fierce)
  • Sharing Older Clinical Trial Data Remains a Problem for Pharma (Pharmalot)

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US: Pharmaceuticals and Biotechnology

  • Senate Republicans seek reforms for NIH, FDA (BioCentury) (Report)
  • Obama Wants $10M for FDA to Help Regulate Precision Medicine (NYTimes) (MIT) (Reuters) (SCRIP-$) (Modern Healthcare-$)  (WaPo)
  • FDA OK's 2 HIV drugs: BMS' Evotaz, J&J's Prezcobix (SCRIP-$) (Pharmafile) (Janssen PR) (BMS PR)
  • Pharmacyclics/Janssen win FDA OK for Imbruvica in Waldenstrom's (SCRIP-$) (Press) (BioCentury) (FDA) (Reuters)
  • Sen. Warren Introduces Medical Innovation Act to Increase Federal Investments in Research (Warren)
  • CSA Legislation Reintroduced to Speed Up DEA’s Scheduling of New Medicines and Approval of DEA Manufacturer Registrations in Certain Circumstances; Define “Imminent Danger; and Change the Game for Orders to Show Cause (FDA Law Blog)
  • Minimal Manipulation: Two draft guidances indicate FDA may expand the scope of HCT/P products subject to premarket review (Lexology)
  • FDA's Job Monitoring Drugs Ads is Getting Harder (MM&M)
  • Nanosphere Receives FDA Warning Letter (Street Insider)
  • U.S. Still Pushing for 12-Years Biologics Patent Protection Under TPP (FDAnews-$)
  • The Mind-Numbing Way FDA Uncovers Data Integrity Lapses (Gold Sheet-$)
  • Biosimilars: 2014 Year in Review and 2015 Outlook (Biotech Due Diligence)
  • Projected Timelines for CBER Protocol-Based Mini-Sentinel Medical Product Assessments (Mini-Sentinel)
  • Wyoming Senate Passes Right to Try Bill (Press)
  • Transgenic/Alternative Carcinogenicity Assays: A Retrospective Review of Studies Submitted to CDER/FDA 1997-2014 (PubMed)
  • Five-Fold VTE Risk Seen with Corticosteroids for IBD (MPR)
  • Doctor pleads guilty to giving misbranded drugs (Courier Journal)

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

  • Intercept nabs a 'breakthrough' title for its blockbuster NASH contender (Fierce) (Nasdaq)
  • Stemline Therapeutics Announces SL-701 Granted Orphan Drug Designation for the Treatment of Glioma (Press)

US: Pharmaceuticals and Biotechnology: General

  • Obama to Unveil Research Initiative to Develop Tailored Medical Treatments (NYTimes) (MIT) (Reuters) (SCRIP-$) (Modern Healthcare-$)  (WaPo)
  • FTC’s Provigil Pay-For-Delay Suit Passes Actavis Test: Judge (Law 360-$)
  • Branded drug prices leapt almost 15% last year, led by pain pills, COPD and heart meds (Fierce)
  • States Work to Strike Deals for Hep C Drug Discounts (WSJ-$)
  • When does the biotech party end? (CNBC)

US: Medical Devices

  • CDRH Accounting for Patient Preferencess in Regulatory Approvals Process (FDA) (RTI)
  • Diagnostics makers face regulatory hurdles in animal health market (Fierce)
  • New Q&A on Exporting Devices (FDA)
  • AACC Cautions FDA Against Extraneous Oversight of LDTs (Press)
  • BioStructures wins FDA clearance for bone graft scaffold (Mass Device)
  • Zeltiq gains as FDA clears fat-freezing applicator for lower temps, faster treatment (Fierce)
  • Novel Cervical Retractor Device Gets FDA Clearance (MPR)
  • Capillus Mobile LLLT Device for Hair Regrowth Receives FDA Clearance (Press)

US: Dietary Supplements

  • FDA Announces Lengthy Extension on Comment Period for its "Red Book" Revisions (FDA)
  • NPA’s Fabricant on caffeine: 'We don’t want to get into a position where Senators are using a court of public opinion to regulate the industry' (NI-USA)

US: Assorted And Government

  • Electronic Health Startup Iodine Gets FDA Nod in Data Sharing Project (ReCode)

Upcoming Meetings

Ebola Outbreak

  • Bioethics Commission to Hold Public Meeting to Discuss Considerations and Implications of Public Health Emergency Response with a Focus on the Current Ebola Virus Disease Epidemic (Bioethics)
  • NEJM: Ebola Vax Safe, Generates Antibodies (MedPage Today)

Europe

  • EU report provides basis for effective fight against development of resistant bacteria (EMA)
  • 50 Years of EU Pharmaceutical Legislation (EC)
  • EC Authorizes Merck's Zontivity (EC)
  • EC Authorizes Shionogi's Senshio (EC)
  • No relevant difference in ADRs from biosimilars and originators (GaBi)
  • Patients with rare CF being denied Vertex' Kalydeco (PharmaTimes)

India

  • Patient Groups Raise Ante Against Gilead’s India Deals (PharmAsia-$)
  • India warns drugmakers failure not an option for price data due next week (Fierce)

China

Japan

Canada

Australia

Other International

  • Nigeria Celebrates a Major Milestone in the Fight Against Substandard Medicines (USP)
  • Pakistan's proposed drug-pricing policy, two years in the making, satisfies no one (Fierce)

Clinical Trials

  • Sharing Older Clinical Trial Data Remains a Problem for Pharma (Pharmalot)
  • Risk Management in Clinical Research: Process and Application (GxP Lifeline)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #483 – 30 January 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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