Regulatory Focus™ > News Articles > Regulatory Reconnaissance (16 December 2013)

Regulatory Reconnaissance (16 December 2013)

Posted 16 December 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

Your editor will be on break for the Holiday starting 21 December 2013, and returning on 2 January 2014. Regulatory Reconnaissance will not be published during this time.

In Focus: US

  • Senators: Enough study; take action on patient-centered drug labeling (BioWorld)
  • FDA Strains Under New NDA Review Model; Will Industry Want To Retain It? (Pink Sheet-$)
  • FDA Panelist Had Serious Conflict, Group Charges (MedPage Today)
  • New Medicines Emerge, but Few Blockbusters (WSJ-$)
  • The Selling of Attention Deficit Disorder (NYTimes)
  • FDA-hit Indian pharma looks to beef up whistlebower policies (Financial Express)
  • FDA Greenlights Magnetic Device for Migraine (MedPage Today) (FDA)
  • Should Consumers Skip the Supplements? (NYT)

In Focus: International

  • An Update on the EU Overhaul of the Medical Device Regulation (Medical Devices Legal)
  • AstraZeneca, BMS pull Forxiga in Germany in snit over pricing (Fierce) (PMLive) (Pharma Times)
  • NICE must get tougher on pharma, urges BMJ journal (Pharmafile)
  • China arrests 1,300 people suspected of making and selling fake medicines (Guardian)
  • China FDA Orders Hep B Vaccine Suspended After Two Infant Deaths (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • Senators: Enough study; take action on patient-centered drug labeling (BioWorld)
  • FDA Strains Under New NDA Review Model; Will Industry Want To Retain It? (Pink Sheet-$)
  • FDA Panelist Had Serious Conflict, Group Charges (MedPage Today)
  • The Selling of Attention Deficit Disorder (NYTimes)
  • FDA-hit Indian pharma looks to beef up whistlebower policies (Financial Express)
  • Gilead's HIV triple therapy Complera Given New Approval by FDA (Pharma Times) (Press) (Pharma Letter-$)
  • FDA OK's CSL Behring's Kcentra in surgery use (SCRIP-$) (Press)
  • Hill Hearing Casts Spotlight On FDA Drug Approval Process (Pink Sheet-$)
  • Alexion Expands Recall of Soliris, Citing Particle Contamination (Press)
  • FDA Encouraged Illegal Compounding, K-V Tells DC Circ. (Law 360-$)
  • BIO, AdvaMed Support Budget Action to Free Up FDA User Fees (BIO) (AdvaMed)
  • Group petitions FDA to overturn rescission of ANCHOR SPA (BioCentury)
  • US generic drug fee relief plan may especially benefit Indian companies (India Times)
  • US Gov: Is UN chemical weapons treaty bad for biopharma business? (BioPharma Reporter)
  • FDA in 2014: Innovation, Partnership and Quality (RPM Report-$) (Hamburg Speech)
  • FDA Generics Office Sheds Almost Half its Staff in Restructure (Pink Sheet-$)
  • AstraZeneca looks to combos after effective ex-Ardea drug shows serious adverse effects (SCRIP-$) 
  • The FDA is cracking down on antibiotics on farms. Here's what you should know. (Washington Post)
  • Two More Issues With FDA's New 'Rules' On Antibiotic Use In Livestock (Forbes)
  • Opinion: Meningitis Outbreaks Call for FDA Leadership. Don't Hold Your Breath. (Forbes)
  • 483 to API Manufacturer Jacobus Pharmaceutical Co. (FDA)
  • FDA announces Rx Formulation's voluntary recall of sterile drug products (FDA)
  • FDA Presentation: "Future Activity of ICH From the FDA Point of View" (FDA)
  • FDA Presentation: "Benefit-risk balance assessment during life cycle of medicinal products" (FDA)
  • FDA Presentation: "Counterfeit Products:The dangers they pose to patients and practitioners" (FDA)
  • FDA Presentation: "Impact of PDUFA V from the risk management perspective - Where it is and where to go" (FDA)
  • FDA Presentation: "Transforming Professional Medical Education: Role of FDA" (FDA)

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

  • Hepatitis C: Phase III data show Boehringer Ingelheim's faldaprevir is effective even in patients with common drug-resistant viral variant (Press)
  • Cubist Announces Positive Top-Line Results from Phase 3 Trial of Ceftolozane/Tazobactam in Intra-Abdominal Infections (Press)
  • AstraZeneca's Lesinurad meets in Phase III gout trial (BioCentury)
  • Lundbeck says to launch new Alzheimer drug in 2017 (Reuters)
  • A Revolution is Taking Place in the Treatment of Blood Cancers (Xconomy)

US: Pharmaceuticals and Biotechnology: General

  • New Medicines Emerge, but Few Blockbusters (WSJ-$)
  • Are Drugmakers Earning A Sufficient Return On Their Investments? (Forbes)
  • Drug abusers may be injuring pets to get pain killers (AJC)
  • Will Pricing For Gilead's Sovaldi Set A Ceiling In HCV, Lead To A Price War? (Pink Sheet-$)
  • FDA Submits Pediatric Use Guidance to OMB (FDA)

US: Medical Devices

  • FDA Greenlights Magnetic Device for Migraine (MedPage Today) (FDA)
  • Why the US FDA's proposed rule on clinical investigations is causing a global stir (Clinica-$)
  • Siemens, Pfizer to cooperate on diagnostic tests (Reuters)
  • Roche pairs Ventana breast cancer test with two more of its blockbuster drugs (Fierce)
  • Canica Design lands FDA approval for cleft palate device (Mass Device)
  • Medtronic Recall Raises Red Flag For Drug-Coated Balloons Below The Knee (Gray Sheet-$)
  • Class 1 Recall for GE Healthcare's Multi Absorber (FDA)
  • Interested in Frugal Innovation and Global Health? The NIH May Have a Grant For You (MDDI)

US: Dietary Supplements

  • NYT Op-Ed: Skip the Supplements (NYT)
  • The risky business of dietary supplements (Dallas News)

US: Assorted And Government

  • US Capitol Capsule: Timid tiptoeing? Antibiotic efforts panned (SCRIP-$)
  • Politics cited in regulatory delays (The Hill)

Upcoming Meetings And Events

  • 17 December 2013: Risk Communication Advisory Committee Meeting (FDA)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

Asia

  • China arrests 1,300 people suspected of making and selling fake medicines (Guardian)
  • China FDA Orders Hep B Vaccine Suspended After Two Infant Deaths (PharmAsia-$)
  • Japan University in Novartis Diovan Trials Denies Data Manipulated (PharmAsia-$)
  • Regenerative Medicine Policy In Japan Could Serve As Global Breeding Ground For New Technologies (PharmAsia-$)
  • GSK scandal ensnares Shanghai official as China probe widens  (SCRIP-$)
  • Pakistan: Vaccine Teams Attacked (NYTimes)

Other International

  • Health Canada Approves Hepatitis C Drug Sofosbuvir  (Press)

General Regulatory And Interesting Articles

  • Central site monitoring: Results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection (SAGE)
  • Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum (Biopharm International)
  • Five Musts for Pharmaceutical Dusts (PharmaManufacturing)
  • Assessing Participant-Centered Outcomes to Improve Clinical Research (NEJM)
  • Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process (Sage)
  • Presenting Quantitative Information About Placebo Rates to Patients (SAGE)
  • Jack Fishman, Inventor of Naloxone, Dies at 83; Saved Many From Overdose (NYTimes)

Regulatory Reconnaissance #222 - 16 December 2013

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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