Regulatory Focus™ > News Articles > Regulatory Recon: FDA AdComm Recommends Female Libido Drug Flibanserin (5 June 2015)

Regulatory Recon: FDA AdComm Recommends Female Libido Drug Flibanserin (5 June 2015)

Posted 05 June 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA AdComm Recommends Female Libido Drug Flibanserin (5 June 2015)

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

In Focus: US

In Focus: International

  • Not quite there: EU medtech guidelines revision sign-off delayed (SCRIP RA-$)
  • Drug Affordability a Top Agenda Item for Upcoming EU Presidency (Politico)
  • NICE U-turn on Janssen arthritis drug Stelara (Pharmafile)
  • NICE wants cost data on BioMarin's Vimizim (BioCentury)
  • NICE backs Bayer's Xofigo but rejects Ferring's Firmagon (PharmaTimes)

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US: Pharmaceuticals and Biotechnology

  • FDA panel backs female sex pill, but multiple caveats (SCRIP-$) (Law 360-$) (Fierce) (Tarius) (NBC) (BioCentury) (MedPage Today) (WSJ-$) (Pink Sheet-$) (Pharmalot) (Reuters)
  • PhRMA's Clinical Trials Results Policy Goes Into Effect (PhRMA)
  • FDA staff: Sanofi/Regeneron drug lowers LDL; is well tolerated (Reuters)
  • New FDA Regulations for Drug Importers Only One Month Away (Registrar Corp)
  • Details Emerge on Phase Two of ISPE’s Quality Metrics Pilot Program (FDAnews-$)
  • The FDA's Sentinel Initiative  (Health Affairs)
  • Expanding Access to Experimental Drugs (Duane Morris)
  • FDA Posts Advisory Committee Materials for Discussion About How to Communicate the Fetal Effects of Methadone or Buprenorphine for Opioid Addiction (Tarius)
  • Product Liability Hopping & the FDA’s Generic Drug Proposal – Awful Together (D&D Law)
  • DEA Proposes to Remove Cocaine Derivative [123I]Ioflupane from Schedule II of the CSA – Almost Five Years after Receipt of HHS’s Recommendation (FDA Law Blog)
  • SmartLipo365 Issues Voluntary Nationwide Recall of Smart Lipo Due to Undeclared Sibutramine, Desmethylsibutramine, and Phenolphthalein (FDA)

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

  • Retrophin Receives Fast Track Designation for RE-024 for the Treatment of Pantothenate Kinase-Associated Neurodegeneration (Press)
  • Imbruvica beats chlorambucil in Phase III CLL/SLL trial (BioCentury)
  • Edge Therapeutics Receives FDA Orphan Drug Designation for EG-1962 for the Treatment of Patients with Subarachnoid Hemorrhage (Press)

US: Pharmaceuticals and Biotechnology: General

  • Big Pharma's making a big push on TPP (Politico)
  • House backs state medical marijuana laws (AP)
  • Florida doctor accused of giving cancer patients unapproved drugs (AP)
  • Amgen Subpoenas a Journalist as it Fights a Shareholder Lawsuit (Pharmalot)

US: Medical Devices

  • Potential Legal Pitfalls for Developers of Health-Related Apps (MDDI)
  • FDA Authorizes Emergency Use of Ebola Diagnostic Device (FDA)
  • DOJ’s Frequent Med Device Enforcement Targets (LifeSciCompliance-$)
  • Senate Eyes CLIA Reform; House Floats Alternative LDT Plan; Industry Split (IHP-$)
  • FDA Review Trends: Medtronic/Covidien Dominate 510(k) Clearance Tally (Gray Sheet-$)
  • Medtronic Receives FDA Clearance of MiniMed Connect for More Convenient Access to Personal Diabetes Data (Press)
  • FDA Reclassifies Nonroller-Type Cardiopulmonary Bypass Blood Pumps (FDA)
  • FDA Approves Another Breast Implant (RTT)
  • Roche receives FDA clearance for the cobas Cdiff Test to detect Clostridium difficile (Press)
  • Recall for Baxter's VASCU-GUARD Peripheral Vascular Patch Due to Risk of Blood Clots (FDA)

US: Dietary Supplements

  • Durbin’s DoD Supplement Proposal Could Be ‘Back Door’ To Pre-market Approval Rule (Tan Sheet-$)
  • AHPA responds to Attorneys General letter to the FDA (NewHope360)
  • Prison for woman who replaced fish oil with seizure meds and stool softeners (AP)

US: Assorted And Government

  • FDA Enforcement Report - Week of June 3, 2015 (FDA)

Upcoming Meetings and Events

Europe

  • Not quite there: EU medtech guidelines revision sign-off delayed (SCRIP RA-$)
  • NICE U-turn on Janssen arthritis drug Stelara (Pharmafile)
  • NICE wants cost data on BioMarin's Vimizim (BioCentury)
  • Drug Affordability a Top Agenda Item for Upcoming EU Presidency (Politico)
  • NICE backs Bayer's Xofigo but rejects Ferring's Firmagon (PharmaTimes)
  • Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis (EMA)
  • Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal  medicinal products (EMA)
  • How patients are helping Scotland say yes to more medicines (SCRIP-$)
  • Aveo planning tivozanib MAA (BioCentury) (Fierce)
  • EU drug agency sees no U.S.-like cannabis legalization moves (Reuters)

India

  • Drug evergreening strategies in India (GaBi)

Japan

  • Japan aims for high-end drug-device innovation and generics, but will it work? (Fierce)

China

  • FDA And CFDA Regulators Talk Up Innovation, Convergence (PharmAsia-$)

General Regulatory And Interesting Articles

  • South Koreans squabble about MERS as more cases appear (Reuters)
  • New Claritin Flamethrower Incinerates Whatever Causing Allergies (The Onion-SATIRE)

Regulatory Reconnaissance #570 – 5 April 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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