Regulatory Focus™ > News Articles > Regulatory Recon: FDA Outlines Personalized Medicine Plan (19 February 2015)

Regulatory Recon: FDA Outlines Personalized Medicine Plan (19 February 2015)

Posted 19 February 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Outlines Personalized Medicine Plan (19 February 2015)

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

In Focus: US

  • FDA Outlines Plan for Expected $10M Under President's Precision Medicine Plan (GenomeWeb) (BioCentury)
  • FDA's 510(k) Pathway Under Attack by Activists (MDDI)
  • Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises (GxP Lifeline)
  • IPEC raises concerns over FDA guidance related to inactive ingredients (In-Pharma)
  • REMS: Would You Balk at Disclosing Confidential Information to Your Competitors? (FDA Law Blog)
  • How Will FDA Treat Apotex's Biosimilar Application in Light of its Five Warning Letters? (Policy and Medicine)
  • Roche gets priority review for melanoma drug cobimetinib (PharmaTimes) (Nasdaq) (Press)
  • Is Robert Califf too Close to Industry to Become FDA Commissioner? (TIME)

In Focus: International

  • Germany in push to encourage antibiotics development (Reuters)
  • New Landmark in fight against counterfeit medicines with establishment of the European Medicines Verification System (EFPIA)
  • Pharma and NICE reject view NHS pays too much for meds (PharmaTimes) (Pharmafile) (OnMedica) (MNT) (Guardian)
  • PhRMA Spies Opportunities Amid ‘Remarkable’ Japan Improvements (PharmAsia-$)
  • Indian Industry Calls for Improvements in Regulatory Overhaul Bill (PharmaBiz)
  • Why is Health Canada still approving make-believe ‘homeopathic vaccines’? (NationalPost)

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US: Pharmaceuticals and Biotechnology

  • IPEC raises concerns over FDA guidance related to inactive ingredients (In-Pharma)
  • REMS: Would You Balk at Disclosing Confidential Information to Your Competitors? (FDA Law Blog)
  • How Will FDA Treat Apotex's Biosimilar Application in Light of its Five Warning Letters? (Policy and Medicine)
  • There Must Be Some Misunderstanding: FDA Issues New Guidance On Disclosing Risk Information In Consumer-Directed Print Advertisements And Promotional Labeling For Human Prescription Drugs (AGG)
  • FDA Rejects Citizen Petition for Generic Cozaar (FDA)
  • Compassionate Use Petition Passes 200,000 Signatures (Change.org)
  • Patent Attack Strategies: Mylan’s Copaxone Petitions Show Power Of Inter Partes Review (Pink Sheet-$)
  • Remicade's U.S. patent rejection could open up early rivalry with Celltrion biosim (Fierce)

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

US: Pharmaceuticals and Biotechnology: General

  • The Evolution Of Biotechnology And Its Impact On Health Care (Health Affairs-$)
  • Drugs, insurance costs behind latest spike in healthcare spending (ModernHealthcare)
  • Crown the new drug launch king: Gilead's Harvoni has knocked aside sister med Sovaldi (Fierce)
  • Why Big Pharma Must Cure Its Bad Rap (Forbes)
  • Amphastar pays some rebates after price of overdose drug doubles (Fierce)

US: Medical Devices

  • FDA Outlines Plan for Expected $10M Under President's Precision Medicine Plan (GenomeWeb) (BioCentury)
  • FDA's 510(k) Pathway Under Attack by Activists (MDDI)
  • Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises (GxP Lifeline)
  • Supply Chain Security Targeted By Draft Legislation – But How Burdensome Might It Be? Experts Weigh In (Silver Sheet-$)
  • Class 1 Recalls for GE, AllTech Devices (FDA) (FDA)
  • Improving Compliance, Increasing Innovation (MDS)
  • FDA approves Sonoma's FibuLock Nail for ankle fractures (Mass Device)
  • FDA Raises Fracture Questions With VertiFlex’s Superion Interspinous Spacer (Gray Sheet-$)
  • Regulatory Uncertainty Causing Retesting Confusion for Patients Considering New Ovarian Cancer Rx (GenomeWeb-$)

US: Dietary Supplements

  • Warning letter slams coconut oil marketer over disease claims (NI-USA)
  • Supplement Industry Increasing Pressure on NY AG's Office (NewHope360)
  • Takeaways From NY's Dietary Supplement Investigation (Law 360-$)
  • Judge Shutters Dietary Supplement Business That ‘Played Cat-And-Mouse Game’ (NPI)

US: Assorted And Government

  • Is Robert Califf too Close to Industry to Become FDA Commissioner? (TIME)

Upcoming Meetings

Europe

  • Germany in push to encourage antibiotics development (Reuters)
  • New Landmark in fight against counterfeit medicines with establishment of the European Medicines Verification System (EFPIA)
  • Pharma and NICE reject view NHS pays too much for meds (PharmaTimes) (Pharmafile) (OnMedica) (MNT) (Guardian)
  • Norgine finally wins NICE nod for Targaxan (SCRIP-$) (PMLive) (MNT)

India

  • IPA suggests nine proposals to Union govt to be included in D&C Amendment Bill 2015 (PharmaBiz)
  • NPPA issues show cause notice to medical device cos for not submitting price list in Form V (PharmaBiz)
  • Pharma companies blame archaic law for lack of swine flu drugs (India Times)

Japan

  • PhRMA Spies Opportunities Amid ‘Remarkable’ Japan Improvements (PharmAsia-$)
  • Eisai Receives Approval In Japan For Fine Granule Formulation Of Anti-Arrhythmic Agent Tambocor Suitable For Pediatric Patients (Press)

Canada

  • Why is Health Canada still approving make-believe ‘homeopathic vaccines’? (NationalPost)

Australia

  • Australian Regulators Warn Over Purcahsing Medicines on the Internet (TGA)

Other International

  • WHO urges developing countries to fund tropical diseases fight (WHO) (Reuters)

General Regulatory And Interesting Articles

  • Map of Second Genetic Code, the "Epigenome," Is Unveiled (Reuters) (Washington Post)
  • National Geographic Show Underworld, Inc Dives Into Issue of Fake Pharmaceuticals (NatGeo)
  • New Approach to Blocking H.I.V. Raises Hopes for an AIDS Vaccine (NYTimes) (Press) (MPR)
  • Pharmaceuticals in the environment: a growing problem (PharmJournal)
  • New male birth control options in the works (MedCityNews) (Wired)
  • Pain Really Is All In Your Head. Emotion Controls Intensity (NPR)

Regulatory Reconnaissance #497 – 19 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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