Regulatory Focus™ > News Articles > Regulatory Recon: FDA Discusses New Authority to Destroy Spurious Imported Drugs (30 September 2015)

Regulatory Recon: FDA Discusses New Authority to Destroy Spurious Imported Drugs (30 September 2015)

Posted 30 September 2015 | By Michael Mezher 

Regulatory Recon: FDA Discusses New Authority to Destroy Spurious Imported Drugs (30 September 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher@Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • National Preparedness Month: FDA and Access to Medical Countermeasures During Public Health Emergencies (FDA Voice)
  • Destroying Certain Imported Drugs: A New Rule to Protect Patients (FDA Voice)
  • Cancer Drugs Aren't As Cost-Effective As They Used To Be (Forbes)
  • Trashed Tests Put FDA on Notice as China Pushes Drug Exports (Bloomberg)
  • Real Precision Medicine Requires Real Access To Patient Data (Forbes)

In Focus: International

  • WHO ramps up HIV drug push with call for early treatment for all (Reuters) (Washington Post) (WHO)
  • UK Extends Drug, Device Accelerated Access Review Project (SCRIP-$) (GOV.UK)
  • Milestone drug approvals on a single day pave way for new therapies in Japan (BioSpectrum)
  • Japan First To Approve Omarigliptin, Lusutrombopag (SCRIP-$) (PharmAsiaNews-$)

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US: Pharmaceuticals and Biotechnology

  • Drug industry must address image problem over prices: Teva executive (Reuters)
  • Sanofi's Praluent And Amgen's Repatha Now Set For Battle In Europe, US (Pink Sheet-$)
  • Who's most at risk if the U.S. cracks down on prices? Gilead, Celgene top the list (FiercePharma)
  • HHS sponsors development of drug for hospitalized influenza patients (PharmaLetter-$)
  • A <797> Rewritten with Patient Safety in Mind (USP)
  • FDA Recruiting for Assistant Commissioner for Global Regulatory Policy (USAJobs)
  • Opinion: Is the First Amendment being "Hijacked" for Off-Label Drugs? (NYTimes)
  • Opioid Use For Chronic Pain Would Be Restricted Under CDC Guideline (Pink Sheet-$)

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

  • Another Positive Phase III For Lilly's, Incyte's Baricitinib (SCRIP-$) (PMLive)
  • Clovis NSCLC Drug Rociletinib Wins FDA Priority Review (SCRIP-$)
  • Ignyta Announces Initiation of STARTRK-2 Phase 2 Clinical Trial of Entrectinib (Press)
  • Cerulean Announces CRLX101 Advances to Second Stage of Phase 2 Clinical Trial of CRLX101 in Combination with Avastin® in Relapsed Ovarian Cancer (Press)
  • Important New Data from Teva's TEV-48125 Phase 2B Migraine Program Published in Lancet Neurology in Back-to-Back Articles (Press)
  • Trevena Announces Publication of TRV130 Phase 2 Bunionectomy Data in the Journal PAIN (Press)
  • Xadago® (safinamide) New Drug Application Late-Cycle Review Meeting Completed with U.S. FDA (Press)
  • Jazz Pharmaceuticals Announces U.S. FDA Acceptance for Filing with Priority Review of NDA for Defibrotide for Hepatic Veno-Occlusive Disease (Press)

US: Medical Devices

  • FDA permits marketing of new laser-based hearing aid with potential for broad sound amplification (FDA)
  • FY2016 MDUFA User Fees (FDA)
  • Nanoparticles Made from Platelets Cloak Cancer Drug, Attack Tumors and CTCs (MassDevice)
  • New Test Detects All Viruses That Infect People, Animals (ICT)
  • Intact Vascular Announces Conditional FDA Approval for Tack Optimized Balloon Angioplasty II (TOBA II) Study and Enrollment of First Patients (Press)
  • FDA Approves Expanded Use of Innovative Trial System for Incontinence Therapy (Press)

US: Assorted and Government

  • Section 510(k) Clearance: While it Doesn't Support Preemption, Is It Relevant Evidence at Trial? (Drug and Device Law)
  • FDA’s Seventh Annual Report to Congress on 505(q) Citizen Petitions: A Lot of the Same Old Same Old (FDA Law Blog)
  • Opinion: A Clintonian Misdirection on Drug Prices (WSJ-$)
  • Sen. Sanders Urges US To Back Drug Patent Exception (Law360-$)
  • M.D. Fla. Shuts Down Attempted End-Run Around Learned Intermediary in Enbrel Case (Drug and Device Law)
  • Bernie's Papal Indulgences (DrugWonks)

Upcoming Meetings and Events              

Europe

  • CHMP recommends 19 new medicines for European approval (PMLive)
  • 'Club Together On Drug Pricing,' EU Health Chief Tells Member States (SCRIP-$)
  • Approach To '2nd Medical Use' Claims Varies Across EU (Law360-$)
  • Generics Industry Prescribes Remedies For EU Regulatory Sprawl (SCRIP-$) (Pink Sheet-$)
  • EFPIA Launches Robust Principles to Secure a Competitive European Off-Patent Biologic Medicines Market (EFPIA)
  • Two men sentenced for illegal supply of defective medicines (MHRA)
  • French pharma representative body hits back at "blatant inadequacy" of social security financing law (PharmaLetter-$)
  • WP7 SG2 Core protocol Pilot for AEG available (EUnetHTA)
  • ClarVista wins CE Mark for Harmoni modular intraocular lens (MassDevice)
  • Occlutech wins CE Mark for VSD closure device (MassDevice)
  • Florida startup nabs CE mark for antimicrobial, intravenous UV light therapy (FierceMedicalDevices)
  • Dyax Corp. Receives Positive Opinion for Orphan Medicinal Product Designation in EU for the Treatment of Hereditary Angioedema (Press)

India                                                                        

  • ICRIER advocates dynamic and responsive regulation to handle drug quality, safety issues (PharmaBiz)
  • India may battle malaria on its own as international agencies plan to divert finances (Economic Times)
  • Pharmexcil to send delegation to Ghana to promote Indian Pharmacopoeia (PharmaBiz)
  • Top health ministry officials visit Gujarat to meet key stakeholders (PharmaBiz)
  • Katoch committee recommends revival of PSUs for manufacturing critical drugs like penicillin, paracetamol, etc (PharmaBiz)

China

  • China’s New Stem Cell Guidelines To Shake Up Industry? (PharmAsiaNews-$)

Japan

  • Soft tissue sarcoma drug approved in Japan (BioSpectrum)
  • Submission of a Supplemental New Drug Application for ASP1585 Granule,a Treatment for Hyperphosphatemia, in Japan (Press)

Canada

Other International

  • 20th AHWP Annual Meeting Program (Agenda)
  • Singapore invests $17 mn in synthetic biology (BioSpectrum)

General Health and Other Interesting Articles

  • What did medical devices look like back in 1850? (MedCityNews)
  • U.S. biotech to apply artificial intelligence to UK genome study (Reuters)
  • Evolution of Extensively Drug-Resistant Tuberculosis over Four Decades: Whole Genome Sequencing and Dating Analysis of Mycobacterium tuberculosis Isolates from KwaZulu-Natal (PLoS)
  • Medical Marijuana Helps. Now, How to Pay for It? (Medpage Today)

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 @Michael_Mezher 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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