Regulatory Focus™ > News Articles > Regulatory Recon: Former FDA Commissioner Testifies Against J&J (29 January 2015)

Regulatory Recon: Former FDA Commissioner Testifies Against J&J (29 January 2015)

Posted 29 January 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Former FDA Commissioner Testifies Against J&J (29 January 2015)

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

In Focus: US

  • Ex-FDA Chief Says J&J Knew Adolescent Risperdal Risks (Law 360-$) (Philly Pharma) (Bloomberg)
  • Pfizer paid $400M to dispatch an investor suit over off-label marketing allegations (Fierce)
  • Iodine Inc. Awarded $1.17 Million Contract from the Food and Drug Administration for OpenFDA project (Press)
  • Personalized Medicine May Necessitate Increased Focus On Drug Quality (Pink Sheet-$)
  • IBM Lobbies Congress to Avoid Having FDA Regulate its Disease-Diagnosing Supercomputer (Bloomberg)
  • FDA Denies Petition to Ban Dental Amalgam (FDA) (FDA) (FDA) (FDA)
  • FDA Commissioner Hamburg Discusses LDT Regulation, Personalized Medicine Advancements (GenomeWeb)

In Focus: International

  • Cautious optimism follows results from trials of early Ebola vaccine (Guardian) (Reuters)
  • CDSCO Formalizes Presubmission Meetings for Drugmakers (FDAnews-$) (CDSCO)
  • Consumer Groups Urge Europe not to Approve the Orexigen Diet Pill (Pharmalot)
  • Drug shortages: it’s time for Europe to act (PharmJournal)
  • An ‘expensive’ placebo is more effective than a ‘cheap’ one, study shows (Washington Post) (NYTimes) (MNT)

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US: Pharmaceuticals and Biotechnology

  • Ex-FDA Chief Says J&J Knew Adolescent Risperdal Risks (Law 360-$) (Philly Pharma) (Bloomberg)
  • Pfizer paid $400M to dispatch an investor suit over off-label marketing allegations (Fierce)
  • Iodine Inc. Awarded $1.17 Million Contract from the Food and Drug Administration for OpenFDA project (Press)
  • Personalized Medicine May Necessitate Increased Focus On Drug Quality (Pink Sheet-$)
  • Study questions FDA warning over adverse cognitive effects of statins (PharmJournal)
  • The way we use antibiotics is broken. Blame nearly a century of drug marketing. (Washington Post)
  • Ranbaxy earnings pulled back down by manufacturing issues (Fierce)
  • Reflections On The Remarkable Rise Of Orphan Drugs (Law 360-$)
  • Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop (FDA)
  • Wyoming Senate passes “right to try” bill on third reading (Star Tribune)
  • How Large is Large? A New Parameter is Set for Pay-to-Delay Cases (Pharmalot)
  • New Bill in Arizona Would Alter Definition of "Misbranded" (Bill)

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

  • Amgen banking on three launches in 2015 (PMLive) (Fierce)
  • Novartis reports positive results from Jakavi Phase III trial in patients with polycythemia vera (PBR) (Press)
  • FDA Grants Orphan Drug Designations to OncoMed's Tarextumab for the Treatment of Pancreatic and Small Cell Lung Cancer (Press)
  • FDA grants orphan drug status for RestorGenex' RES-529 to treat glioblastoma multiforme (PBR)
  • Novartis points to PhIII flaws to explain weak Jetrea sales (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • Obama precision medicine plan would create huge U.S. genetic biobank (ScienceMag)
  • Biopharma CEOs summoned to White House for precision med reveal  (SCRIP-$) (CNBC)
  • Precision Medicine: What's It Worth? (MedPage Today) (NYTimes)
  • Study Finds H.I.V. Drugs Priced Out of Reach (NYTimes)

US: Medical Devices

  • IBM Lobbies Congress to Avoid Having FDA Regulate its Disease-Diagnosing Supercomputer (Bloomberg)
  • FDA Denies Petition to Ban Dental Amalgam (FDA) (FDA) (FDA) (FDA)
  • FDA Commissioner Hamburg Discusses LDT Regulation, Personalized Medicine Advancements (GenomeWeb)
  • LDT Regulation: Future of Personalized Medicine at Stake (MendelsPod) (2)
  • CDRH Sets Performance Goals (iMarc)
  • FDA Refuses to Reclassify two AEDs Made by Philips Healthcare (FDA)
  • How to Effectively Respond to FDA 483s (MDDI)
  • 10 Inspection Questions Answered By 3 FDA Device Investigators (Silver Sheet-$)
  • Venaxis' appendicitis test not found equivalent to standard care (Reuters)
  • Medtronic CoreValve safer than surgery in bypass patients: study (Reuters)
  • Getinge sees end of FDA woes as Q4 profit lags forecast (Reuters)
  • That Israeli startup with the vibrating anti-constipation pills is conducting clinical trials stateside (MedCityNews)
  • Bioceptive's novel women's health device receives FDA clearance (MNT)
  • DePuy Synthes Spine receives 510(k) clearance to market SYNAPSE OCT System with posterior cervical screws (Press)
  • Bioceptive Suction Cervical Retractor Lands FDA Clearance (MedGadget)
  • AliveCor Announces FDA Clearance for Two New Automated Detectors for Normal Recordings and Noise Interference (Press)
  • ZELTIQ Receives FDA Clearance to Perform CoolSculpting Procedure at Lower Temperatures for Shorter Treatment Times (Press)

US: Dietary Supplements

  • Ingredient Suppliers’ Role in Safe Supplements (NPI)

US: Assorted And Government

  • A Blizzard of Antiregulatory Bills in Congress (CPR)
  • Bill requires annual agency spending reports (The Hill)
  • PhRMA Weighs in on the TPP Agreement and Global IP Protections (PhRMA)
  • PCORI to create communications panel, test PCORnet (BioCentury)

Upcoming Meetings

Ebola Outbreak

  • In Ebola response, Big Pharma and public sector strive to make up for lost time (Global Post)
  • Cautious optimism follows results from trials of early Ebola vaccine (Guardian) (Reuters)
  • Ebola Outbreak on The Decline, Says WHO (WSJ-$)

Europe

  • Consumer Groups Urge Europe not to Approve the Orexigen Diet Pill (Pharmalot)
  • Drug shortages: it’s time for Europe to act (PharmJournal)
  • Boehringer attacks French HTA body's downgrading of Pradaxa (SCRIP-$)
  • Roche Pharma reviews the HTA Core Model from a pharmaceutical perspective (EUnetHTA)
  • Biosimilar Interchangability: When Irish Eyes Aren't Smiling (DrugWonks)
  • EU unannounced audits turn commercial relations into marriages (Clinica-$)
  • PhEur 8th Edition: 3 monographs will be suppressed on 1 January 2016 (EDQM)
  • Blue Belt Technologies Announces CE Mark for STRIDE Unicondylar Knee System (Press)

India

  • CDSCO Formalizes Presubmission Meetings for Drugmakers (FDAnews-$) (CDSCO)
  • Gilead to launch generic Sovaldi in India this summer (BioPharmaDive) (Fierce)
  • DCGI to renew focus on NE states to assess drug quality and GMP standards (PharmaBiz)

China

  • China FDA approves Agilent's microarray scanner for in vitro diagnostics (Fierce)
  • Chinese Pharmacopoeia venture up and running as safety push continues (Fierce)

Australia

  • Anaesthetists call for restrictions on drug used in cough medicine (ABC)

Other International

  • Vietnamese police seize 10 tonnes of fake supplements (Securing Industry)
  • IEC 60601-1-2:2014 (4th ed.) What is the Impact of this Puzzle on Your Product Design? (Eisner)

Clinical Trials

  • Researchers discuss challenges in reporting trial results (AllTrials)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #482 – 29 January 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 @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.


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