Regulatory Focus™ > News Articles > Regulatory Recon: FDA Review Pans Testosterone Drugs (4 September 2014)

Regulatory Recon: FDA Review Pans Testosterone Drugs (4 September 2014)

Posted 04 September 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Review Pans Testosterone Drugs (4 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here.

In Focus: US

  • FDA: Little Evidence to Support Testosterone Drugs (AP) (BioCentury)
  • FDA Advisory Committee Unanimously Agrees with FDA-Proposed Standards for OTC Antiseptics Used in Healthcare Settings (SAC)
  • Perdue Foods says its chicken hatcheries now antibiotic-free (Reuters) (NYTimes) (The Hill) (Pew) (NPR)
  • CDER’s Counter-Terrorism, Emergency Coordination Operations Get New Home (Pink Sheet-$)
  • Chinesa Resources Sanjiu Medical and Pharmaceutical Co put on Import Alert Over GMP Deficiencies (FDA)
  • FDA orders iRadimed to submit new 510(k) after site inspection, stock tanks (Mass Device)
  • J&J Unit Ran ‘Amok’ Marketing Pinnacle Hips, Jury Told (Bloomberg)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • FDA: Little Evidence to Support Testosterone Drugs (AP) (BioCentury)
  • FDA Advisory Committee Unanimously Agrees with FDA-Proposed Standards for OTC Antiseptics Used in Healthcare Settings (SAC)
  • Perdue Foods says its chicken hatcheries now antibiotic-free (Reuters) (NYTimes) (The Hill) (Pew) (NPR)
  • CDER’s Counter-Terrorism, Emergency Coordination Operations Get New Home (Pink Sheet-$)
  • Chinesa Resources Sanjiu Medical and Pharmaceutical Co put on Import Alert Over GMP Deficiencies (FDA)
  • CHPA “Neutral” On Requiring Deadlines For TEA Reviews (Tan Sheet-$)
  • FDA Limits on Antibacterial Healthcare Ingredients Could Put Patients, Employee Safety at Risk, Says ACI (Press)
  • FDA Making Minor Changes to Promo Section of eCTD (FDA)
  • Safety Petition Against Baxter’s Immune Globulin HyQvia Could Limit Use (Pink Sheet-$)
  • DMD Group Submits Cardiac Recommendations to FDA (PPMD)
  • Nearly 90,000 ED visits annually linked to psychiatric drug events (Modern Healthcare)
  • Zoetis granted conditional license by USDA for PEDv vaccine (Fierce) (AP)
  • Kentucky Horse Racing Commission looking into regulating compounders (Fierce)

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

  • Cleveland BioLabs Announces Green Light to Submit Pre-Emergency Use Authorization Application for Entolimod (Press) (BizJournal)
  • Merck’s Investigational Beta-lactamase Inhibitor Relebactam (MK-7655) Granted Qualified Infectious Disease Product (QIDP) and Fast Track Designations by FDA (Press)
  • Debiopharm Group's Innovative Antibiotic Debio 1450 Receives Qualified Infectious Disease Product (QIDP) Designation from the FDA (Press)
  • FDA Grants Fast Track Designation to Aradigm’s Pulmaquin for Non-Cystic Fibrosis Bronchiectasis (Press)
  • Flexion’s Slow-Release Steroid Now On Faster Track With FDA (Pink Sheet-$)
  • Tetraphase up on Phase III cUTI data (BioCentury)
  • Mallinckrodt Pharmaceutical’s MNK-155, an Extended-Release Hydrocodone/Acetaminophen Combination, Shows Efficacy in Phase 3 Acute Pain Trial (Press)
  • Edison's EPI-743 misses Rett syndrome endpoint (BioCentury) (SCRIP-$)
  • Celgene Trial of Revlimid + Dexamethasone Meets PFS Endpoint in Multiple Myeloma Trial (Press)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • FDA orders iRadimed to submit new 510(k) after site inspection, stock tanks (Mass Device)
  • J&J Unit Ran ‘Amok’ Marketing Pinnacle Hips, Jury Told (Bloomberg)
  • Sham Controls in Medical Device Trials (NEJM)
  • 510(k) Clearance Database (Socrata)
  • CeloNova BioSciences Receives Expanded Indication in Liver Cancer (Press)
  • Stereotaxis Gets FDA Clearance To Market Vdrive With V-Loop System (RTT) (BizJournal)
  • Esaote Receives FDA Clearance for Its Compact MyLab Six Ultrasound System (Press)
  • Boston Scientific's WallFlex fares well in biliary stenting study (Mass Device)
  • Weight loss: EnteroMedics' VBLOC therapy fails to meet clinical trial targets (Mass Device)

US: Dietary Supplements

  • Negotiating the New Dietary Ingredient Notification Process (NPI)

US: Assorted And Government

  • Physician Payments Sunshine Act: Physician Review Period Marred By Technical Difficulties, Missing Payments, and Uncertainty (PolicyMed)
  • Upton, BIO Discuss Adding National Alzheimer's Study To E&C Innovation Bill (IHP-$)

Upcoming Meetings

Ebola Outbreak

  • FDA Gives NewLink Genetics Approval to Proceed to Phase 1 Clinical Studies of Their Ebola Vaccine (Press) (Reuters)
  • Canada Ebola vaccine shipment to Africa stymied by logistics (Reuters)
  • J&J Ebola vaccine to start clinical trials in early 2015 (Reuters) (WSJ-$) (Fierce) (Bloomberg) (Pharma Times)
  • UK volunteers sought for Ebola vaccine trial (FT-$)
  • Experts Meet to Advise WHO on How to Use Experimental Ebola Drugs, Vaccines (PharmPro)
  • WHO declares Ebola epidemic a 'global threat' (The Hill)
  • Ebola deaths near 2,000; outbreak to cost $600m+ (SCRIP-$)

Europe

  • NICE backs Alexion's Soliris (Pharmafile) (BioCentury) (SCRIP-$) (Pharma Times) (Press)
  • IQWiG Sees Value In Olysio, As Janssen Looks To Link It With Sovaldi (Pink Sheet-$)
  • Diabetes: Abbott wins E.U. approval for wearable glucose sensor (Mass Device) (Fierce)
  • EndoCross Receives CE Mark Approval for the ENABLER-C Coronary Catheter System for the Crossing of Coronary Chronic Total Occlusions (Press)
  • Prosonix MAA for Generic Asthma Drug Under Assessment in EU (Press)
  • Despite a late-stage flop, Kamada preps its orphan drug for EMA review (Fierce)
  • Domperidone's OTC status withdrawn on heart effects (Pharma Times)

India

  • India’s Compulsory License Debate Set For A Comeback (PharmAsia-$)
  • India battles HIV/AIDS drug shortage as some firms halt supply (Reuters)
  • Expert panel on FDC to hold seventh meeting on Sept 5 to assess safety and efficacy of several FDCs (PharmaBiz)

China

  • Chinese Authorities Search for Whereabouts of Toxic Capsules (NYTimes) (Fierce) (ECNS)
  • Chinese ‘Viagra’ gets approval (ECNS)
  • CFDA Finds Quality Problems In Latest Probe (PharmAsia-$)

Japan

  • Severe Skin Symptoms Prompt Japan SGLT2 Warning (PharmAsia-$)
  • Bayer seeks Japanese approval for Eylea injections (Reuters) (SCRIP-$)

Other International

  • Asian regulators set year-end target for white paper on combination product rules (Clinica)
  • South Korea lifts ban on zilpaterol feed additives in beef (Fierce)

General Regulatory And Interesting Articles

  • Content review systems for the Social Media Age (PharmaPhorum)
  • Why this crab's blood could save your life (CNN)

Regulatory Reconnaissance #392 – 4 September 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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