Regulatory Recon: FDA AdComm Wants Limits on Use of Low-T Drugs (18 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, or check out some of the mostnews-worthy sessions here.

In Focus: US

• FDA Panel Recommends More Study on Testosterone Drugs for 'Low-T' Use (WSJ-$) (AP) (Reuters) (Pink Sheet-$) (NYTimes) (Tarius) (Fierce) (Bloomberg)
• Ebola fuels debate over speeding up trials for experimental drugs (The Hill)
• FDA Considers Providing Mid-Review Update For First Generics (Pink Sheet-$)
• Faster-acting erectile dysfunction drug gets FDA approval  (Reuters) (Press)
• FDA OKs 1st glucose meter with insulin calculator (Mass Device)
• Will Boston's lackluster Watchman data scupper FDA panel vote? (Clinica-$)
• Weight Loss Products Provide More Targets In FDA War On Spiked Supplements (Tan Sheet-$)

In Focus: International

• NICE urges review of new drug adoption policies, offers "reset" relationship with industry (FT-$) (PharmaPhorum) (BioCentury) (Pharma Times)
• Health Canada wants drug shipments from IPCA Laboratories halted (Canadian Press) (Press)
• Bad Vaccine Kills Dozens of Children Inside Syria (NYTimes) (Reuters) (AP)
• ICH elemental impurities guideline expected to be finalized at end of September (In-Pharma)
• Has Gilead bottled the Indian compulsory licensing genie? (SCRIP-$)

US: Pharmaceuticals and Biotechnology

• FDA Panel Recommends More Study on Testosterone Drugs for 'Low-T' Use (WSJ-$) (AP) (Reuters) (Pink Sheet-$) (NYTimes) (Tarius) (Fierce) (Bloomberg)
• Ebola fuels debate over speeding up trials for experimental drugs (The Hill)
• FDA Considers Providing Mid-Review Update For First Generics (Pink Sheet-$)
• Faster-acting erectile dysfunction drug gets FDA approval  (Reuters) (Press)
• ANDAs Get More Time – Or Maybe Less – To Correct Minor Deficiencies (Pink Sheet-$)
• Ranbaxy Nexium Generic Still Not Launched Despite Approval (PharmAsia-$)
• Natco Pharma, Orchid Chemicals get Form 483s from FDA (Financial Express)
• Messed-Up Clinical Studies: A First-Hand Report (In the Pipeline) (Skeptoid)
• Targeting a Competitor's Brand Name with Keywords (RegulatoryRx)
• FDA Perspectives in Clinical Trials With FDA's Director of the Office of Scientific Investigations (BioClinica)
• Why you should be paying attention to the lawsuit against Actavis (CNBC)
• Patient Input at the FDA: Who, What, Why & When? (Modern Medicines)
• The Myths Behind the "Even the Score" Campaign (PharmedOut-PDF)
• Biden presses Colombia to block biosimilar drugs (KEI)
• Baxter issues recall, this time because antibacterial gets mixed in wrong carton (Fierce)

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

• Flexion tanks as FDA clamps a hold on its lead osteoarthritis drug (Fierce) (Press) (BioCentury)
• Novo's Ryzodeg effective in type 2 diabetes treatment: study (Reuters)

US: Pharmaceuticals and Biotechnology: General

• Tramadol’s Newfound Natural Product Status In Doubt (CEN)
• Analysis of “Real World” Sovaldi (sofosbuvir) Use and Discontinuation Rates (CVS-PDF)

US: Medical Devices

• FDA OKs 1st glucose meter with insulin calculator (Mass Device)
• Will Boston's lackluster Watchman data scupper FDA panel vote? (Clinica-$)
• 'Sham' Renal Denervation Defended (MedPage Today)
• July 2014 PMA Approvals (FDA)
• EOS imaging Receives FDA Clearance for New Software Dedicated to Sagittal Balance and Posture Analysis (Press)
• Thermo Fisher Scientific Announces Listing of the Ion PGM Dx System with the U.S. FDA as Class II Medical Device (Press)

US: Dietary Supplements

• Weight Loss Products Provide More Targets In FDA War On Spiked Supplements (Tan Sheet-$)
• Bayer-FTC issue: ‘Be as careful with your implied claims & testimonials as you are with the express claims’ (NI-USA)
• Supplement Makers Pay $3M To End Joint Health False Ad Suit (Law 360-$)

Upcoming Meetings

• RAPS' FDA Scientific Advisory Committee Meeting Tracker

Europe

• NICE urges review of new drug adoption policies, offers "reset" relationship with industry (FT-$) (PharmaPhorum) (BioCentury) (Pharma Times)
• European Commission 'has limited power to tackle drug pricing' (PharmaPhorum)
• NICE backs new hep C, melanoma drugs (Pharma Times)(Reuters) (BioCentury) (BioCentury)
• EuropaBio calls for EMA action on labeling of biosimilars (Pharma Letter-$)

India

• Health ministry to conduct all India survey on extent of availability of spurious drugs (PharmaBiz)
• Has Gilead bottled the Indian compulsory licensing genie? (SCRIP-$)

Canada

• Health Canada wants drug shipments from IPCA Laboratories halted (Canadian Press) (Press)

Other International

• Drug shortages in developed countries-reasons, therapeutic consequences, and handling (PubMed)
• Bad Vaccine Kills Dozens of Children Inside Syria (NYTimes) (Reuters) (AP)
• ICH elemental impurities guideline expected to be finalized at end of September (In-Pharma)
• The Human Impact of Counterfeit and Substandard Medicines (USP)
• Global Challenges of Medical Device Recalls (ExpertRecall)
• 'Fastest way to biosimilar approval? As the CRO flies,' says industry group (Biopharma Reporter)

Clinical Trials

• FDA Perspectives in Clinical Trials With FDA's Director of the Office of Scientific Investigations (BioClinica)

Regulatory Reconnaissance #402 – 18 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 [email protected].

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