Regulatory Focus™ > News Articles > Regulatory Recon: FDA Won't Place Serious Warning on Testosterone Products (17 July 2014)

Regulatory Recon: FDA Won't Place Serious Warning on Testosterone Products (17 July 2014)

Posted 17 July 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Won't Place Serious Warning on Testosterone Products (17 July 2014)

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

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In Focus: US

  • FDA Rejects Petition to Label Testosterone Products With Black Box (FDA) (Pharmalot)
  • Safety Trolls?: Generic Firms Seek To Invalidate Xyrem REMS Patent Via PTO (Pink Sheet-$)
  • Another Citizen Petition Calls for 5-Year Exclusivity for Fixed-Dose Combination Drug (FDA Law Blog)
  • Sunscreen Regulation Bill Advances in House (E&C) (Press) (The Hill)
  • ‘SWAT Teams’ Recommended For Device Firms As They Handle Product Recalls (Gray Sheet-$)
  • FDA rejects ban on pelvic mesh, supports reclassification (Mass Device) (Fierce)

In Focus: International

  • EMA releases final guideline on stroke prevention in AF (BioCentury) (EMA)
  • EU notified bodies work to clarify key medtech risk management standard (Clinica-$)
  • GSK admits to 2001 China bribery scandal (CNBC)
  • India Out With New Trial Injury Compensation Expectations (PharmaBiz)

US: Pharmaceuticals and Biotechnology

  • FDA Rejects Petition to Label Testosterone Products With Black Box (FDA) (Pharmalot)
  • Safety Trolls?: Generic Firms Seek To Invalidate Xyrem REMS Patent Via PTO (Pink Sheet-$)
  • Another Citizen Petition Calls for 5-Year Exclusivity for Fixed-Dose Combination Drug (FDA Law Blog)
  • Sunscreen Regulation Bill Advances in House (E&C) (Press) (The Hill)
  • BMJ Study Says Results Contained in Former PhRMA Registry Often Missing (AllTrials) (BMJ)
  • FDA, CDC and NIH to Hold Meeting on Antimicrobial Resistance (FR)
  • OTC Emergency Asthma Inhaler NDA Survives, Needs Additional Studies (Tan Sheet-$)
  • Salix and Pharming Announce FDA Approval of RUCONEST for the Treatment of Acute Angioedema Attacks in Patients with Hereditary Angioedema (HAE) (Press)
  • Baxter issues global recall of saline in midst of U.S. shortage (Fierce) (FDA)
  • Josh Hardy, Boy at Center of Compassionate Use Case, Improves Enough to Leave Hospital (WRAL) (WWBT)
  • GSK recalls acetaminophen products that were not child-proofed (Fierce)

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

  • New Evidence Fuels Concerns About The Safety Of Niacin (Forbes) (NBC) (NYTimes)
  • Boehringer's lung drug wins FDA 'breakthrough' tag (Fierce) (Press) (Pharma Times)
  • New England Journal of Medicine publishes Ipsen’s Somatuline CLARINET Phase III results in patients with metastatic gastroenteropancreatic neuroendocrine tumors (Press)
  • FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Candidiasis (Press)
  • Roche Reports Mixed Results in Trial of an Alzheimer’s Drug (NYTimes) (AP) (Forbes)
  • Microbiome Company Seres to Apply for Breakthrough Status for its C-Diff Product (Xconomy)

US: Pharmaceuticals and Biotechnology: General

  • Will Gilead’s Hepatitis C Drug Bust State Budgets? (Pharmalot)
  • Each of these Hepatitis C pills cost $1,000. That's actually a great deal. (Vox)
  • Costly Vertex Drug Is Denied, and Medicaid Patients Sue (WSJ-$)
  • Is Truvada, the Pill to Prevent H.I.V., 99 Percent Effective? Don’t Be So Sure (The Upshot)
  • Janssen's tramadol supply chain ready for DEA's rescheduling deadline (In-Pharma)

US: Medical Devices

  • ‘SWAT Teams’ Recommended For Device Firms As They Handle Product Recalls (Gray Sheet-$)
  • FDA rejects ban on pelvic mesh, supports reclassification (Mass Device) (Fierce)
  • Australian clinical activity tracker gets FDA clearance (MobiHealthNews)
  • Cerus Submits Final Module in Premarket Approval (PMA) Application Process for INTERCEPT Platelets (Press)
  • Carmat Shares Soar as Artificial Heart Trials Are Resumed (Bloomberg)
  • Bausch + Lomb's VICTUS Femtosecond Laser Platform Receives 510(k) Clearance from FDA for Lens Fragmentation Procedure (Press)
  • IBA Receives FDA Approval Of Its New Compact Gantry Clearing The Way For Proteus One (Press)
  • FDA Approves the Freedom® Portable Driver That Powers The SynCardia Total Artificial Heart (Press)

US: Dietary Supplements

  • Supplement Industry group welcomes Steroid legislation, even with last minute ‘technical changes’ (NI-USA)

US: Assorted And Government

  • Maryland Looks to Develop Life Science Hub Next to FDA HQ (WaPo)

Europe

  • EMA releases final guideline on stroke prevention in AF (BioCentury) (EMA)
  • Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolic risk in non-surgical patients (EMA)
  • EU notified bodies work to clarify key medtech risk management standard (Clinica-$)
  • AllTrials strongly supports HRA proposals on registration and reporting (AllTrials)
  • On the Regulation of 3D Printing in the EU (MedicalDevicesLegal)
  • Achieving market access in the UK with a little help from Patient Access Schemes (PharmaPhorum)

India

  • DCGI directs clinical trial sponsors & cos to give compensation in drug-related anomaly discerned later (PharmaBiz)

China

  • GSK admits to 2001 China bribery scandal (CNBC) (Reuters)

Japan

  • Past Indiscretions Haunt Novartis and Japan’s Clinical Trials Industry (PharmAsia-$)
  • Astellas Japan Files For Additional Indication Of Irribow For Women (PharmAsia-$)

General Regulatory And Interesting Articles

  • Gene therapy creates a ‘biological pacemaker’ that could someday replace implanted ones (Reuters) (WaPo) (WSJ-$) (NYTimes)
  • Can Deep Brain Stimulation Treat Anorexia? (Aeon)
  • Scientific review finds asthma drugs suppress child growth (Reuters) (MNT)

Regulatory Reconnaissance #359 – 17 July 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.

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.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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