Regulatory Focus™ > News Articles > Regulatory Recon: PDUFA VI, Senate Committee OKs FDA Funding Bill (16 July 2015)

Regulatory Recon: PDUFA VI, Senate Committee OKs FDA Funding Bill (16 July 2015)

Posted 16 July 2015 | By Michael Mezher 

Regulatory Recon: PDUFA VI, Senate Committee OKs FDA Funding Bill (16 July 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 and @RAPSorg on Twitter.

In Focus: US

In Focus: International

  • AdvaMed: Bill in India Distinguishes Between Drugs and Medical Devices (Economic Times)
  • Data management, SOP deficiencies cited often after 2014 GCP inspections, EMA report finds (Outsourcing-Pharma)
  • France's AB Science hit with FDA warning letter over clinical trials (Outsourcing-Pharma)
  • Bad News from Europe for Makers of Life-Saving Medical Devices (Drug and Device Law)
  • One in five prescription interventions relate to drug shortages (PJ Online-$)
  • Improve Quality or you are Out, Says China FDA Commissioner (PharmAsiaNews-$)
  • CFDA eyes new Shanghai evaluation center to speed drug approvals (FiercePharmaAsia) ( CCTV)
  • Japan to demand more clinical data in product reviews; joins single-audit pilot (Clinica-$)
  • How Much Acetaminophen a Day is Safe? Health Canada to Review Max Dosage (The Star) (ProPublica) (Health Canada)

US: Pharmaceuticals and Biotechnology

  • Gardasil HPV Vaccine Safety Assessed in Most Comprehensive Study to Date (Forbes)
  • Infographic: The Rising Tide of Cancer Drug Costs (MedCityNews)
  • Will Bovine Heparin Be Reintroduced into the U.S. Market? (Quality Matters)
  • Life ban for founder of fake US drug company with $12m in sales (In-Pharma Technologist)

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

  • Fujifilm Submits First PMA Module for Digital Breast Tomosynthesis (Press)
  • Immunovaccine's DPX-Survivac Receives Orphan Drug Designation from the FDA (Press)
  • Anisina Receives Orphan Drug Designation from FDA for Neuroblastoma (Press)
  • Cellceutix's Kevetrin Receives FDA Orphan Drug Designation (Press)
  • Study: Diabetes Drug May Also Treat Hypertension, Cirrhosis (MPR)
  • Delamanid for Extensively Drug-Resistant Tuberculosis (NEJM)
  • Allergan Notes Receipt of Paragraph IV Notification on Restasis (Press)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • 'Smart Capsule' Tested to Improve Drug Delivery, Purdue University Study (BioSpace) (Purdue) (MedGadget)
  • IOL Makers Cleared To Start UDI Database Entry (Gray Sheet-$) (FDA Letter)
  • St. Jude Medical Gets FDA Approval for First Spinal Cord Stimulation Trial System to Incorporate Bluetooth and Apple Devices (Press)
  • Doctors Trial Glasses That Make Cancer 'Glow' (Reuters)
  • Theranos Gets First CLIA Waiver for HSV Test System (Press)
  • Alere Gets CLIA Waiver for Group A Streptococcus Rapid Test (Press)
  • $2 Paper Machine Performs DNA Disease Diagnostics (MedGadget) (Study)
  • Here’s a look at FDA design controls for medial device developers (MedCityNews)
  • ReWalk Robotics's New Exoskeleton Lets Paraplegic Stroll the Streets of NYC (IEEE Spectrum)
  • eMDR Compliance Deadline Looms: Last Minute Tips for Procrastinators (MasterControl)
  • Philips Trilogy Ventilator Boasts Strong Results in COPD Study (MassDevice) (Press)
  • Theranos keys into Medicaid with latest deal in managed care (FierceMedicalDevices) (Press)

US: Assorted and Government

  • Senate subcommittee advances $20.5B bill funding Agriculture, FDA (The Hill)
  • Antibiotic Resistance Targeted in 21st Century Cures Act (MedPageToday)
  • FDA Reboot Needed to Grow Innovation, Senate Panel Told (MedPageToday)

Upcoming Meetings and Events

Europe

  • Data management, SOP deficiencies cited often after 2014 GCP inspections, EMA report finds (Outsourcing-Pharma)
  • BIA and MHRA publish report following joint conference Pathway of Innovation from Research to Patients (MHRA)
  • European Commission Approves Bristol-Myers Squibb’s Evotaz (atazanavir and cobicistat fixed-dose combination) for the Treatment of HIV-1 Infection in Adults (Press)
  • France's AB Science hit with FDA warning letter over clinical trials (Outsourcing-Pharma)
  • Malaria treatment Coartem 80/480mg receives WHO prequalification (European Pharmaceutical Review) (PharmaLetter-$)
  • Bad News from Europe for Makers of Life-Saving Medical Devices (Drug and Device Law)
  • EFPIA Statement on the Ongoing Greek Economic Crisis (EFPIA)
  • Hemispherx Biopharma Seeks Orphan Designation for MERS Treatment (Press)
  • One in five prescription interventions relate to drug shortages (PJ Online-$)
  • UK Marketing Authorizations Granted in June 2015 (MHRA)

India

  • AdvaMed: Bill in India Distinguishes Between Drugs and Medical Devices (Economic Times)
  • NPPA fixes price of 39 drug formulation packs (Economic Times)
  • SC asks government to review its market-based drug pricing policy within six months (Economic Times)

China

  • Improve Quality or you are Out, Says China FDA Commissioner (PharmAsiaNews-$)
  • CFDA eyes new Shanghai evaluation center to speed drug approvals (FiercePharmaAsia) (CCTV)

Japan

  • 2015 a year to watch out for authorized generics and biosimilars in Japan (PharmaLetter-$)
  • Japan to demand more clinical data in product reviews; joins single-audit pilot (Clinica-$)

Canada

Other International

  • Korean Pharma Urged To Focus On Emerging Market Exports (PharmAsiaNews-$)
  • Singapore Develops Novel Cancer Drug Candidate (BioSpectrum)
  • Malaysia to soon become Asia's medical device manufacturing hub (BioSpectrum)
  • Pfizer opens Center of Excellence in Precision Medicine in Chile (FierceDiagnostics)
  • International Health Regulations Turn Ten (CDC)

General Regulatory and Interesting Articles

  • Tiny beating human heart made from scratch (New Scientist) (PopSci) (Nature)
  • Biohackers Aim To Make Homebrew Insulin, But Don't Try It Yet (NPR)
  • First Human Case of West Nile Virus in 2015 Confirmed (MPR)
  • New drug delivery methods are making taking medicine easier for everyone (MedCityNews)
  • Genetic validation of drug targets improves chance of success (PJ Online-$)
  • Use of antibiotics in young children may disrupt gut microbiome (PJ Online-$)

Regulatory Reconnaissance #597 – 16 July 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 @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.


Categories: Recon, Regulatory News

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