Regulatory Focus™ > News Articles > Regulatory Recon: FDA's Woodcock Explains Agency's Biosimilars Stance (14 October 2014)

Regulatory Recon: FDA's Woodcock Explains Agency's Biosimilars Stance (14 October 2014)

Posted 14 October 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA's Woodcock Explains Agency's Biosimilars Stance (14 October 2014)

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

In Focus: US

  • FDA's Woodcock lays out path for biosimilars to be interchangeable (BioCentury-$) (BCTV)
  • Clinical Evidence Supporting Pharmacogenomic Biomarker Testing Provided in FDA-Approved Drug Labels (JAMA)
  • Texas AG Lawsuit Claims AstraZeneca Improperly Marketed Seroquel (Pharmalot) (Fierce)
  • Small Uptick In 510(k) Clearances In Fiscal 2014 (Gray Sheet-$)
  • FDA's Schwartz: Devices without vendor support 'enormous challenge' for cybersecurity (Fierce)
  • Researcher: FDA Cyber Security Guidance Will Help ‘Stop the Bleeding’ (MDDI)

In Focus: International

  • China military-linked firm eyes quick approval of drug to cure Ebola (Reuters) (Pharmafile)
  • Biosimilars going global but EMA still setting the regulatory pace (BioPharma-Reporter)
  • IPEC calls for inclusion of excipient compound monographs in Ph. Eur. (In-Pharma)
  • Scots recommend ultra-orphan Adcetris in bumper round of approvals (SCRIP-$) (SMC)
  • India’s Intas Under Vietnamese Regulatory Lens? (PharmAsia-$)
  • India Set For New Study On Spurious Drugs (PharmAsia-$)
  • How best to share data on problematic devices? IMDRF wants to know (Clinica-$)

US: Pharmaceuticals and Biotechnology

  • FDA's Woodcock lays out path for biosimilars to be interchangeable (BioCentury-$) (BCTV)
  • Clinical Evidence Supporting Pharmacogenomic Biomarker Testing Provided in FDA-Approved Drug Labels (JAMA)
  • Texas AG Lawsuit Claims AstraZeneca Improperly Marketed Seroquel (Pharmalot) (Fierce)
  • FDA: Engaging with patients and structuring benefit-risk assessment (FasterCures)
  • Case study: Duchenne muscular dystrophy (FasterCures)
  • Successful patient engagement in drug development (FasterCures)
  • MMR Vax Proves Safe Over Time in U.S. Adults (MedPage Today)
  • Thanks to resistance, drug companies retiring antibiotic after antibiotic (MedCityNews)

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

  • AbbVie pivotal phase III study evaluating HUMIRA in the expanded indication of moderate-to-severe hidradenitis suppurativa meets primary endpoint (RTT)
  • US: Pharmaceuticals and Biotechnology: General
  • The top 10 most expensive drugs of 2013 (Fierce)
  • Former Rep.: FDA should play key role in lower drug costs (The Hill)
  • Sources: Ranbaxy's key U.S. operations losing top dogs (Fierce) (Pharmalot) (India Times)
  • Harvoni OK triggers rush to three-drug hep C combos (EP Vantage-$)
  • Payers hit back at Gilead for $94,500 price tag on brand-new hep C combo pill (Fierce)
  • Study Examines How Doctors Use Prescription Drug Monitoring Programs (AP)

US: Medical Devices

  • Small Uptick In 510(k) Clearances In Fiscal 2014 (Gray Sheet-$)
  • FDA's Schwartz: Devices without vendor support 'enormous challenge' for cybersecurity (Fierce)
  • Researcher: FDA Cyber Security Guidance Will Help ‘Stop the Bleeding’ (MDDI)
  • Quidel Receives FDA Clearance for Its Lyra Molecular PCR Assay for the Detection of Adenovirus (Press)

US: Dietary Supplements

  • Justice Department Says Its Interpretation of Dietary Supplement FTC Standard Isn’t 'Novel' (NPI)

US: Assorted And Government

  • New Batch of FDA Warning Letters Posted (FDA)
  • Medical Money: See What Drug and Device Makers Paid Doctors (Pharmalot)

Upcoming Meetings

Ebola Outbreak

  • China military-linked firm eyes quick approval of drug to cure Ebola (Reuters) (Pharmafile)
  • Ebola Gorilla Vaccine Could Prevent Human Outbreaks (SciAm)
  • Debate Over Ebola Turns to Specific Policy Requests (NYTimes)
  • Nurse gets Ebola survivor plasma; ZMapp maker ups efforts (SCRIP-$)
  • Ebola vaccines progress; NewLink spikes (SCRIP-$)

Europe

  • Biosimilars going global but EMA still setting the regulatory pace (BioPharma-Reporter)
  • IPEC calls for inclusion of excipient compound monographs in Ph. Eur. (In-Pharma)
  • Scots recommend ultra-orphan Adcetris in bumper round of approvals (SCRIP-$) (SMC)
  • Drug complexity will change how Big Pharma uses Ph. Eur. says Pfizer expert (In-Pharma)
  • EMA Considering How to Set up Clinical Trials Transparency Database (EMA)
  • UK 'one-stop shop' for regenerative medicines advice (PharmaTimes)
  • NICE working to tackle antimicrobial resistance (PMLive)

India

  • India’s Intas Under Vietnamese Regulatory Lens? (PharmAsia-$)
  • India Set For New Study On Spurious Drugs (PharmAsia-$)
  • India's NPPA fines Novartis $49M as price cap battles rage on (Fierce)
  • Is India right on its processes but wrong on its drug quality? (S4S)
  • Government drags feet on effective anti-TB drug Bedaquiline (India Times)
  • NPPA issues Internal Guidelines for making representation to NPPA against price notifications (PharmaBiz)

Australia

  • Confusing Syringe Design Leads to GSK Recall of Children's Panadol (TGA)

Other International

  • How best to share data on problematic devices? IMDRF wants to know (Clinica-$)
  • Thailand Industry Seeks PIC/S Membership for Thai FDA (Bangkok Post)

General Regulatory And Interesting Articles

  • Sample Size Determination for Individual Bioequivalence Inference (PubMed)
  • Light-activated drug could reduce side effects of diabetes medication (Press)

Regulatory Reconnaissance #420 – 14 October 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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