Regulatory Reconnaissance: Evidence Behind FDA Approvals Varies Widely (22 January 2014)

Posted 22 January 2014 | 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:

In Focus: US

In Focus: International

US: Pharmaceuticals/Biotechnology

  • Quality Of Evidence Used By FDA To Approve New Drugs Varies Widely (Study) (Forbes) (Washington Post) (WSJ-$) (Press) (NEJM) (Modern Healthcare) (Fierce) (MNT) (Bloomberg)
  • Many Drug Approval Delays, Denials Could Be Prevented, FDA Study Shows (Pink Sheet-$) (JAMA)
  • FDA Often Looks Outside The Application, Review Documents Show (PAM-$)
  • FDA rejects wider use of Amag's anemia drug (Reuters) (Press)
  • Amarin Vows Appeal of FDA Rejection of SPA (Fierce) (SCRIP-$) (Pink Sheet-$) (Law 360-$)
  • Court Decision: Fentanyl Patch's Status as a "Combination Product" Does not Preempt Claims (CA Court)
  • Looking Back Down the Road - What Have We Learned from FDA on Regulation of Digital Media? (Eye on FDA)
  • CBER New Biologic Tally Healthy In 2013, But For Innovation Look To 2014 (PAM-$)
  • New Drugs In 2013 Show A Virtuous Cycle: First-Cycle Approvals Up, Review Times Down (PAM-$)
  • Incorporating Risk-Based Asset Management into Your Drug Shortage Prevention Program (Pharma Manufacturing)
  • Saline shortage: FDA works with Baxter, Hospira and Braun (Fierce)
  • Indian pharma companies secure 154 ANDAs approval from US FDA during 2013 (PharmaBiz)
  • How the DQSA Will-And Won't-Protect The Supply Chain (RxTrace)
  • AstraZeneca Seeks Full Rehearing Of Generic Drugmaker Win (Law 360-$)
  • NAD Refers Salonpas Ad Claims To FDA, FTC (Law 360-$)

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

  • Vivus/Auxilium seek prescribing change for Stendra (SCRIP-$)
  • Forest planning NDA for ceftazidime/avibactam (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • Yellowstone managers reject vaccinating bison with biobullets (Reuters)
  • Vivaldi inks NIAID CRADA for H7N9 vax, as infections top 200 (SCRIP-$)
  • Reversal Over Sacked Gay Juror To Guide Pharma Trial Jury Selection (Law 360-$) (Reuters)

US: Medical Devices

  • 2013's top FDA approvals in med tech (Fierce)
  • A Search Engine Medical Device Designers Should Fear (QMED)
  • Forward-Looking Device Makers Should Embrace FDA's Unique Device Identifier System (MDDI)
  • PSM Releases Report On Black Market IUDs At U.S. Clinics (Safe Medicines)
  • Orfit Receives FDA Clearance for Nanor Technology (Press)
  • Covidien Receives U.S. Food and Drug Administration Clearance for LigaSure Maryland Jaw (Press)
  • BioPhotas, Inc. Announces FDA OTC Clearance of the Celluma, an Innovative Light Therapy Device to Treat Skin, Joint and Muscle Conditions (Press)
  • Option Elite Retrievable Vena Cava Filter Gains FDA Clearance for a New Over-The-Wire Delivery Technique (MedGadget)
  • ChestMaster Device for Cystic Fibrosis Relief Created by CF Patient (MedGadget)

US: Dietary Supplements

US: Assorted And Government

  • Former FDA Commissioner Andrew von Eschenbach joins Precision Health Economics (BioCentury)

Upcoming Meetings And Events

  • 28 January 2014: Allergenic Products Advisory Committee Meeting (FDA)
  • 28 January 2013: US State of the Union Address (White House)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 29-30 January 2014: Science Advisory Board to the National Center for Toxicological Research Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • AstraZeneca's diabetes drug Xigduo approved in Europe (Reuters) (PMLive) (Pharma Times) (Press) (SCRIP-$)
  • ViiV Healthcare HIV drug Tivicay wins European OK (SCRIP-$) (Pharma News EU) (BioCentury) (MNT)
  • NICE recommends Sanofi's Aubagio as new treatment option for MS (Pharma Letter-$) (PMLive) (MNT) (Pharmafile)
  • Danish government wants action against drug firms who prevent competition (Reuters)
  • New era for migraine treatment as NICE backs TMS (Pharma Times)
  • Trade secrets law reform in the EU: the implications for pharma and medtech (Clinica)
  • Questions & answers on practical implementation of Article 31 Pharmacovigilance Referral (EMA)


Other International

  • Health Canada library changes leave scientists scrambling (CBC)
  • Peruvian regulators update rules for importing unregistered medical devices (Mass Device)

General Regulatory And Interesting Articles

  • Biosimilars: what's in a name? (BMJ)
  • How the Internet Helped Me Cope With My Rare Disease (Atlantic)
  • Meeting Global Pharmacopeia Requirements for Water Compliance (Pharma Manufacturing)
  • Could cold meds help spread the flu? (NBC)

Regulatory Reconnaissance #240 - 22 January 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.

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