Regulatory Focus™ > News Articles > Regulatory Reconnaissance (28 October 2013)

Regulatory Reconnaissance (28 October 2013)

Posted 28 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

  • FDA Shift on Painkillers Was Years in the Making (NYTimes)
  • Gilead's sofosbuvir aces FDA advisory committee (PMLive) (Pink Sheet-$) (Pharma Times) (Press) (MedPage Today)
  • Drug Compounding, Tracing Bill Could Receive Senate Vote Next Week (IHP-$)
  • Margart Hamburg Planning Visit to India in Next Few Months (India Times)
  • India's Sun shares fall after report about U.S. FDA queries (Reuters) (India Times) (Bloomberg)
  • Industry Says MDR Draft Guidance Would Lead To Redundant Reporting (Gray Sheet-$)
  • FDA Cybersecurity Efforts Emphasize Collaboration With Homeland Security Officials, Hospitals (Gray Sheet-$)

In Focus: International

  • 2015, not 2014, looking more likely for EU medtech regs adoption (Clinica-$)
  • Rare EMA-Sanctioned Compassionate Use Program Sends Gilead's Sofosbuvir To Market Early (Pink Sheet-$) (EMA)
  • Indian Health ministry finalises 'Biomedical Research Human Subjects Promotion and Regulation Bill' (PharmaBiz)
  • Meeting highlights from the Latest CHMP Meeting (EMA)
  • Novo Nordisk recalls some NovoMix 30 insulin products in Europe (Pharma Letter-$) (Law 360-$) (EMA) (PMLive)

US: Pharmaceuticals/Biotechnology

  • FDA Shift on Painkillers Was Years in the Making (NYTimes)
  • Gilead's sofosbuvir aces FDA advisory committee (PMLive) (Pink Sheet-$) (Pharma Times) (Press) (MedPage Today)
  • Drug Compounding, Tracing Bill Could Receive Senate Vote Next Week (IHP-$)
  • Margart Hamburg Planning Visit to India in Next Few Months (India Times)
  • India's Sun shares fall after report about U.S. FDA queries (Reuters) (India Times) (Bloomberg)
  • The ABCs Of Accelerated Approval Withdrawals (Pink Sheet-$)
  • FDA Prevails in Challenge to Generic ACETADOTE Approval; Court Grants Summary Judgment (FDA Law Blog)
  • FDA OKs Drug Without Anti-Abuse Protection (Med Page Today) (Pink Sheet-$)
  • Naming Rights: Biosimilar Influence Efforts Continue Before Products Take The Field (Pink Sheet-$)
  • Is It A Rash Or Photosensitivity? FDA May Have To Distinguish Them In Simeprevir Label (Pink Sheet-$)
  • FDA Antibiotic Restrictions Highlighted In Impavido Review (Pink Sheet-$)
  • Would Sponsors Do Earlier Pediatric IBD Studies With Nod From Agency Or Advisory Committee? (Pink Sheet-$)
  • Ariad Expects Narrower Label, Not Withdrawal, For Iclusig Following Halted Study (Pink Sheet-$)
  • AstraZeneca Sues 4 Drugmakers To Stop Generic Vimovo (Law 360-$)
  • Celgene arthritis drug appears effective, safe after one year: study (Reuters)
  • Bristol-Myers adds promising survival update on breakthrough cancer drug (Fierce)
  • Celgene lifted by apremilast data in psoriatic arthritis (PMLive)
  • Boehringer Cites Positive PhIII data for NSCLC Drug Afatinib (Press)
  • New STELARA Data Show Inhibition Of Joint Destruction In Patients With Active Psoriatic Arthritis (Press)

US: Medical Devices

  • Industry Says MDR Draft Guidance Would Lead To Redundant Reporting (Gray Sheet-$)
  • FDA Cybersecurity Efforts Emphasize Collaboration With Homeland Security Officials, Hospitals (Gray Sheet-$)
  • Task Force Collaborating With FDA Issues Pediatric Heart Valve Recommendations (Gray Sheet-$)
  • Ethicon Receives 510(k) Clearance for New HARMONIC ACE+ 7 Shears with Advanced Hemostasis (Press)
  • Hip Implant Recall Costs Could Top $1B, Stryker Says (Law 360-$)

US: Dietary Supplements

  • Novartis OTC Facility Improves Regulatory Report Card (Tan Sheet-$)

US: Assorted And Government

  • Availability of Interaction Profile for Chlorinated Dibenzo-p -Dioxins, Polybrominated Diphenol Ethers, and Phthalates (ATSDR)
  • US Capitol Capsule: Biotech titans prophesy future, as Washington marks industry's birth (SCRIP-$)

Upcoming Meetings And Events

  • 31 October 2013: Data Harmonization for Patient-Centered Clinical Research (IOM/PCORI)
  • 13 November 2013: Vaccines and Related Biological Products 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

  • 2015, not 2014, looking more likely for EU medtech regs adoption (Clinica-$)
  • Rare EMA-Sanctioned Compassionate Use Program Sends Gilead's Sofosbuvir To Market Early (Pink Sheet-$) (EMA)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 October 2013 (EMA)
  • Novo Nordisk recalls some NovoMix 30 insulin products in Europe (Pharma Letter-$) (Law 360-$) (EMA) (PMLive)
  • EMA backs Lundbeck's Brintellix in depression (PMLive)
  • Biogen Idec gains on Tecfidera news (BioCentury)
  • Basilea gains European approval for antibiotic ceftobiprole (SCRIP-$)
  • Actelion's PAH drug Opsumit recommended for EU approval (PMLive)

Asia

  • Indian Health ministry finalises 'Biomedical Research Human Subjects Promotion and Regulation Bill' (PharmaBiz)
  • India API Quality-Inspection Team In China Still Not In Place (PharmAsia-$)
  • Three Biotech Executives Free On Bail In Adulterated Supplement Case (PharmAsia-$)

Other International

  • Time for a global treaty to protect patients against fake and substandard drugs (AEI)
  • SpineGuard Obtains Regulatory Clearance to Sell Pediguard Curved and Curved XS in Mexico (Press)

General Regulatory And Interesting Articles

  • Is It Pharma's Fault That We Don't Have Better Drugs For Malaria, TB And Tropical Diseases? (Forbes)

Regulatory Reconnaissance #189 - 28 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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