Regulatory Focus™ > News Articles > Regulatory Recon: US Elections Preview Major Regulatory Changes (5 November 2014)

Regulatory Recon: US Elections Preview Major Regulatory Changes (5 November 2014)

Posted 05 November 2014 | By Alexander Gaffney, RAC

Regulatory Recon: US Elections Preview Major Regulatory Changes (5 November 2014)

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

In Focus: US

In Focus: International

  • The Medical Innovation Bill: helping patients and innovation, or a prescription for negligence? (PharmaPhorum)
  • Indian Patent office issues final Guidelines for examination of patent applications in pharmaceuticals (PharmaBiz)
  • Canadian drug companies violating the law (The Star)
  • A new bill will make Health Canada’s drug approvals more transparent. In theory, anyway (NationalPost)
  • Surviving ISO 9001:2015 (GxP Lifeline)

US: Pharmaceuticals and Biotechnology

  • Arizona Voters Pass New "Right to Try" Referendum Into Law (Newsweek) (10th Amendment Center) (KPHO) (Governing)
  • Novartis gears up for FDA scrutiny with a new blood cancer drug (Fierce) (Myeloma Beacon) (Tarius) (Pink Sheet-$) (SCRIP-$) (BioCentury)
  • FDA Review of Rockwell's Dialysis Therapy Raises Doubts About Need (The Street) (Tarius) (Fierce) (Pink Sheet-$) (SCRIP-$)
  • GOP Poised To Slow Down Obama Product Safety Measures (Law 360-$)
  • FDA Working With Patients on Multiple Myeloma Master Protocol (Press)
  • FDA warning cites Hikma plant for repeatedly failing to investigate issues (Fierce)
  • FDA Oncology AdComm to Evaluate Synta's Ganetespib (FDA) (Press)
  • OGD Puts the Pedal to the Metal the Last 4 Days of October to Reach 31 Approvals (Lachman)
  • FDA Urged To Ban Drug Coating Chemical (Law 360-$)
  • FDA Appeals Depomed Orphan Drug Case (FDA Law Blog)
  • Statistical Analysis of FDA's Inspection Findings (GMP Compliance)
  • Pfizer Director: Need for regulatory commitments clarity in NDAs, and US FDA concurs (In-Pharma)
  • Combination Products Challenge Biopharma Manufacturers (PharmTechTalk)
  • Getting Potentially Life-Saving Drugs to High-Risk Breast Cancer Patients Faster (FDA)
  • Exclusivity, Labeling Are Sticking Points In FDA-Industry Abuse-Deterrence Talks (IHP-$)
  • J&J Wins Dismissal Of Listerine False Labeling Suit (Law 360-$)
  • CDER: Management of the Regulatory Science and Review Enhancement Program (FDA MAPP)
  • Merck announces approval of secondary feeding label for Zilmax (Drovers) (Press)
  • Phoenix Man Gets Probation for Selling Fake Viagra (AP)
  • Ranbaxy gets USFDA nod to market Fenofibrate capsules (Press)
  • Glenmark Generics Receives Final ANDA Approval for Omeprazole DR Capsules (Press)

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

  • Vertex Submits NDA In U.S. And Europe For Lumacaftor Combined With Ivacaftor (Press)
  • GSK submits asthma biologic in US, EU (PharmaTimes)
  • Amgen's Trebananib Fails to Improve Survival in Phase 3 Ovarian Cancer Study (Press) (BioCentury)
  • Lundbeck's schizophrenia drug wollops competition in novel head-to-head trial (BioPharmaDive) (Press)
  • FDA Grants Orphan Drug Designation To Merrimack Pharmaceuticals' MM-141 For The Treatment of Pancreatic Cancer (Bezinga)

US: Pharmaceuticals and Biotechnology: General

  • SCRIP's New Mini-Site on Antimicrobial Resistance (SCRIP)
  • PATH Malaria Vaccines Initiative nets $156M from Gates Foundation (Fierce)

US: Medical Devices

  • J&J Could Pay $250M To Settle More ASR Hip Implant Suits (MedDeviceOnline)
  • Securing Medical Devices: FDA Guidance and its Implementation (PCM)

US: Dietary Supplements

  • Citing Cohen's research, agency removes DMBA-containing products from military shelves (Nutra Ingredients)
  • Internet helps noncompliant retailers ply their trade but also helps FDA find them, expert says (Nutra-Ingredients)

US: Assorted And Government

  • GOP Senate Will Press FDA To Ease Up (Law 360-$)
  • Less than 3% of Companies on FDA Import Alert Red Lists Petition for Exemption (Press)
  • After Election 2014: 21st Century Cures (ScienceMag)
  • FDA beefs up China office (China Daily)

Upcoming Meetings

Ebola Outbreak

  • How FDA, NIH plan to pull off a randomized, adaptive Ebola trial (BioCentury-$) (In The Pipeline)
  • U.S. Ebola researchers plead for access to virus samples (Reuters)
  • Researchers Seek Crucial Tool: A Fast, Finger-Prick Ebola Test (NYTimes)
  • Ebola in Context (Imgur)

Europe

  • The Medical Innovation Bill: helping patients and innovation, or a prescription for negligence? (PharmaPhorum)
  • EGA and EBG see EMA latest biosimilars guidance as “important step forward” (PharmaLetter-$)
  • Switzerland Hands Out Iodine in Case of Nuclear Disaster (Bloomberg)

India

  • Indian Doctors give drugs without knowing side-effects: Study (India Times)
  • Patent office issues final Guidelines for examination of patent applications in pharmaceuticals (PharmaBiz)

Canada

  • Canadian drug companies violating the law (The Star)
  • A new bill will make Health Canada’s drug approvals more transparent. In theory, anyway (NationalPost)

Australia

Other International

  • ICH Q3D Could Provide Model for More Inclusive ICH Process; Focus Continues on Q3D Implementation Challenges, Including Risk Assessments (IPQ-$)
  • Surviving ISO 9001:2015 (GxP Lifeline)
  • New USP Chapters on Storage and Distribution under Way - but what is the Relevance? (GMP Compliance)
  • ISPE Issues Detailed Quality Metrics Definitions (FDA News)
  • About the International Coalition of Medicines Regulatory Authorities (ICMRA) (TGA)

Clinical Trials

  • Likelihood Ratio-Based Tests for Longitudinal Safety Data (Brookings)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #434 – 5 November 2014

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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