Regulatory Focus™ > News Articles > Regulatory Reconnaissance (29 October 2013)

Regulatory Reconnaissance (29 October 2013)

Posted 29 October 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • JAMA study questions FDA's shorter drug approval times (Reuters) (EurekAlert) (JAMA) (Pink Sheet-$) (MedPage Today)
  • Drug/Diagnostic Co-Development Guidance Coming Soon, But Could Be Outdated Quickly (Pink Sheet-$)
  • AMA warns FDA to weigh unintended consequences of reclassifying hydrocodone (AMA)
  • Patient Experience Still Undervalued in Regulating Drugs (BioWorld)
  • Is Glaxo Keeping Its Commitment To Releasing Paxil Trial Data? (Pharmalot)
  • BIO Disagrees With Lawmakers' View, Says ACA Left Biosimilar Naming To FDA (IHP-$)

In Focus: International

  • Revision of paediatric investigation plan guideline: stakeholder comments sought by European Commission (EMA)
  • ViiV files HIV combo pill Trii in EU (SCRIP-$)
  • Veterinary medicines inch towards a single market (TOPRA)
  • Pharma Trade Groups Team Up In China To Improve Compliance (PharmAsia-$)
  • India's plan to inspect China plants stalled (Fierce)
  • Bombay High Court to begin hearing in Bayer's case against IPAB's Compulsory License order on Nexavar today (PharmaBiz)

US: Pharmaceuticals/Biotechnology

  • JAMA study questions FDA's shorter drug approval times (Reuters) (EurekAlert) (JAMA) (Pink Sheet-$) (MedPage Today)
  • AMA warns FDA to weigh unintended consequences of reclassifying hydrocodone (AMA)
  • Patient Experience Still Undervalued in Regulating Drugs (BioWorld)
  • Is Glaxo Keeping Its Commitment To Releasing Paxil Trial Data? (Pharmalot)
  • BIO Disagrees With Lawmakers' View, Says ACA Left Biosimilar Naming To FDA (IHP-$)
  • Risk-based supply chain management means more audits for excipient firms (In-Pharma)
  • FDA and Partners Launch e-Learning Course on Evaluating Drug Promotion (FDA) (FDA)
  • For personalized medicine, it's back to the future: Pazdur explains (SCRIP-$)
  • Coming Soon: Paradigm Shift In Genetic Resources Regs (Law 360-$)
  • Ohio turns to untried execution drug mix due to shortage of pentobarbital (Guardian)
  • Lundbeck gets U.S. approval for epilepsy drug for children (Reuters) (Press)
  • Maine's Dangerous Drug Scheme (Forbes)
  • HPV Vaccine Less Likely To Help Black Women Because Clinical Trials Were Mostly White (Think Progress)
  • Dow Pharmaceutical Asks Court To Block Generic Acne Gel (Law 360-$)
  • Positive data for BMS' clazakizumab in arthritis (PMLive) (SCRIP-$) (Pharma Letter-$) (Xconomy) (Pharma Times)
  • Coherus reports PK data for Enbrel biosimilar (BioCentury)
  • Synta slides on updated ganetespib data (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • Top 10 Drug Patent Losses of 2014 (Fierce)
  • Rep. Slaughter Calls On Presidential Council of Advisors on Science and Technology to Investigate Antibiotic Resistance Crisis (Slaughter)
  • Unlikely Multiple Sclerosis Pill On Track To Become Blockbuster (NPR)
  • Lawmakers Attempt to Keep Up With Synthetic Drugs (Roll Call)

US: Medical Devices

  • Drug/Diagnostic Co-Development Guidance Coming Soon, But Could Be Outdated Quickly (Pink Sheet-$)
  • U.S. FDA shares more details on MDSAP international audit pilot (Mass Device)
  • Distinguishing Medical Device Recalls (Stericycle)
  • FDA Grants 510(k) Clearance for Innovative Fuse Gastroscope from EndoChoice (Press)
  • Reverse Medical Corporation Announces Regulatory Clearance for ReVerse® 21 and 27 Microcatheters for Neurovascular Indications (Press)
  • St. Jude Medical Reports Positive Clinical Outcomes from Portico Heart Valve Study (Press)
  • Ethicon Receives 510(k) Clearance of Ear, Nose and Throat (ENT) Indication for ENSEAL Tissue Sealers (Press)
  • Bayer's Glucose Meter Receives FDA Approval for Use with Medtronic's New "Artificial Pancreas" (MedGadget)
  • Class 1 Recall: ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) (FDA)
  • Class 1 Recall: PENTAX Endoscopic Accessories (FDA)

US: Assorted And Government

  • Conservatives push for bill checking regulations (The Hill)
  • TPP Countries See Drug-Patent Agreement By Year's End (PharmAsia-$)
  • US Sen. Warren: Boost spending on medical research (AP)
  • US Chamber, Others Push For Bill To Stop Counterfeit Imports (Law 360-$)
  • EBay pushes 'big data' approach to regs (The Hill)

Upcoming Meetings And Events

  • 31 October 2013: Data Harmonization for Patient-Centered Clinical Research (IOM/PCORI)
  • 1 November 2013: Blood Products Advisory Committee Meeting  (FDA)
  • 4-5 November 2013: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 8 November 2013: Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 13 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Revision of paediatric investigation plan guideline: stakeholder comments sought by European Commission (EMA)
  • ViiV files HIV combo pill Trii in EU (SCRIP-$)
  • Veterinary medicines inch towards a single market (TOPRA)
  • IMI launches Call for proposals with focus on flu vaccines (PharmaNewsEU)
  • Boston Scientific bags CE mark for heart valve as market crowds (Fierce) (Mass Device) (Press)

Asia

  • Pharma Trade Groups Team Up In China To Improve Compliance (PharmAsia-$)
  • India's plan to inspect China plants stalled (Fierce)
  • ISCR urges CDSCO to engage state drug control depts to monitor clinical trials (PharmaBiz)
  • Bombay High Court to begin hearing in Bayer's case against IPAB's Compulsory License order on Nexavar today (PharmaBiz)
  • PMDA's Medical Information Project To Improve Adverse Effect Data In Japan (PharmAsia-$)
  • Dainippon Sumitomo Files For Pediatric Indication Of Metgluco In Japan (PharmAsia-$)

Other International

  • Canadian Court Won't Shrink Paxil Birth Defect Class (Law 360-$)

General Regulatory And Interesting Articles

  • Can This Man Make You Believe In Drug Companies? (Forbes)
  • Eisai Begins Free Supply Of Diethylcarbamazine In Line With Its Global Commitment To Eliminate Lymphatic Filariasis (Press)

Regulatory Reconnaissance #190 - 29 October 2013

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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