Regulatory Focus™ > News Articles > Regulatory Recon: FDA Delays Release of Generic Drug Labeling Rule (18 November 2014)

Regulatory Recon: FDA Delays Release of Generic Drug Labeling Rule (18 November 2014)

Posted 18 November 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Delays Release of Generic Drug Labeling Rule (18 November 2014)

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

In Focus: US

  • FDA Delays Final Rule on Allowing Generic Drug Makers to Update Labels (Pharmalot) (Focus Explainer)
  • Ranbaxy Sues FDA Over Nixed Approvals Of Generics (Law 360-$)
  • FDA Mulls Over Results of NEJM Antiplatelet Tx Study (MPR) (FDA) (Pink Sheet-$)
  • The "Vaccine Court" Keeps Claimants Waiting (AP)
  • Lab Group Hires Super Lawyer to Fight FDA's LDT Regulation (GenomeWeb)
  • FDA panel recommends approval of Alcon intraocular lens (Fierce) (Gray Sheet-$) (FDA)
  • Upton: 21st Century Cures Act Will "Speed Up Approval for All Drugs and Devices" (E&C) (1:00 in)

In Focus: International

  • Crisis at the EMA - but might Rasi return? (SCRIP-$)
  • Contraceptive pills available without a prescription under a proposal considered by the Therapeutic Goods Administration (NewsAU)
  • How the biologics landscape is evolving (PharmJournal)
  • Improved Ebola Situation in Liberia May Complicate Vaccine Trials (Scientific American)

US: Pharmaceuticals and Biotechnology

  • FDA Delays Final Rule on Allowing Generic Drug Makers to Update Labels (Pharmalot) (Focus Explainer)
  • Ranbaxy Sues FDA Over Nixed Approvals Of Generics (Law 360-$)
  • FDA Mulls Over Results of NEJM Antiplatelet Tx Study (MPR) (FDA) (Pink Sheet-$)
  • FDA eases up on overall survival requirement with Avastin approval (EP Vantage-$)
  • “Breakthrough” Means Breaking Down Bureaucracy (RPM Report-$)
  • Why ODAC didn't buy Novartis' explanation of panobinostat tox in MM Phase III (BioCentury)

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

  • Novartis heart failure drug provides host of benefits: study (Reuters) (Fierce)
  • FDA orders CytRx to halt patient enrollment after death of a cancer patient (Fierce) (Reuters)
  • Novartis adds to its case for secukinumab for ankylosing spondylitis (Fierce)
  • Merck's Zetia cuts heart attack, stroke risk in long-awaited study (Reuters)
  • Regeneron drug highly effective for those who can't take statins: study (Reuters)
  • PCSK9s Get Boost From IMPROVE-IT; Outcomes Data Restores Faith In LDL Surrogate (Pink Sheet-$)
  • Large Japanese Trial Casts Further Doubt On Aspirin To Prevent A First Heart Attack (Forbes)
  • Celgene's Oral OTEZLA (Apremilast) Showed Sustained Clinical Response over Two Years in Patients with Active Psoriatic Arthritis (Press)
  • Surprise! Vytorin Works. Here Are Five Things You Should Know. (Forbes)
  • NIH-sponsored study identifies superior drug regimen for preventing mother-to-child HIV transmission (NIH)

US: Pharmaceuticals and Biotechnology: General

  • The "Vaccine Court" Keeps Claimants Waiting (AP)
  • How Much Does it Cost to Develop a Drug? New Data Emerging Later Today (Pharmalot)
  • What to look for in the new Tufts study on drug development costs. 10 issues. (KEI)
  • What Effect Will the Sunshine Act Have on the Practice of Medicine? (BioCentury)
  • Generics makers, execs face potential criminal charges in U.S. pricing probe (Fierce)

US: Medical Devices

  • Lab Group Hires Super Lawyer to Fight FDA's LDT Regulation (GenomeWeb)
  • FDA panel recommends approval of Alcon intraocular lens (Fierce) (Gray Sheet-$) (FDA)
  • Should Medical Device Placebos be Used in Trials? (TIE)
  • Pacemakers Get Hacked On TV, But Could It Happen In Real Life? (KHN)
  • 5 Ways Firms Can Use QSIT For Internal Quality Audits (Silver Sheet)
  • Valeant Pharmaceuticals And IDEAL IMPLANT Announce FDA And Health Canada Approval To Market Ideal Implant For Cosmetic Breast Augmentation (Press)
  • Brain tumor treatment device gets early trial halt for efficacy as a combo with chemo (Fierce)
  • Covidien study: VenaSeal effective in treating leg veins (Mass Device)
  • Study: Stent patients benefit from long-term blood thinners (Mass Device)
  • AdvanDx Receives FDA 510(k) Clearance for mecA XpressFISH (Press)
  • Aurora Spine Receives FDA 510(k) Clearance for Pre-Packaged Sterile ZIP 51 MIS Interspinous Fixation Implant (Press)

US: Dietary Supplements

  • New online option for NDI notifications could cut basic errors, expert says (Nutra-Ingredients)

US: Assorted And Government

  • Upton: 21st Century Cures Act Will "Speed Up Approval for All Drugs and Devices" (E&C) (1:00 in)

Upcoming Meetings

Ebola Outbreak

  • Improved Ebola Situation in Liberia May Complicate Vaccine Trials (Scientific American)
  • Ebola Outbreak Draws Investor Attention; Real Impact May Be Clinical Trial Models (RPM Report-$)
  • How Fear of Ebola Is Paving the Way for Poor-Quality Medicines (USP)
  • Nebraska Hospital: Surgeon with Ebola Has Died (AP) (NYTimes) (SCRIP-$)
  • Death of second Ebola patient in U.S. shows need for early, accurate tests, experts say (WaPo)

Europe

  • Crisis at the EMA - but might Rasi return? (SCRIP-$)
  • IntriCon Receives CE Mark for Hearing Aid Products (Press)
  • France's ANSM Releases Data Showing Restrictions on Celgene's Thalidomide Working (ANSM)
  • EMA Budget Recommended for Discharge in Parliament (EUroParl)
  • Celgene Announces Swissmedic Approval of REVLIMID (lenalidomide) for Treatment of Patients with Relapsed or Refractory (Press)
  • pSivida Reports ILUVIEN Granted Marketing Authorization in Ireland (Press)

India

  • Foreign drug makers urge Indian government to review IPR think tank (India Times)

Japan

  • Regeneron Announces EYLEA (aflibercept) Injection Approved for the Treatment of Diabetic Macular Edema (DME) in Japan (Press)

Canada

  • Celgene's OTEZLA (apremilast tablets), First in a New Class of Oral Treatment, Receives Health Canada Approval for Plaque Psoriasis (Press)

Australia

  • Contraceptive pills available without a prescription under a proposal considered by the Therapeutic Goods Administration (NewsAU)
  • Australian to Unveil New Software for eCTD submissions in 2015 (TGA)

Other International

  • South Africa to Spend $2.2 billion on HIV Drugs in Next 2 Years (Scientific American)
  • Presbia Flexivue Microlens Receives Approval from Korean Ministry of Food and Drug Safety (MFDS) (Press)

Clinical Trials

  • GlaxoSmithKline is testing mobile health sensors for clinical trials (MobiHealthNews)

General Regulatory And Interesting Articles

  • How the biologics landscape is evolving (PharmJournal)
  • Can psychedelic trips cure PTSD and other maladies? (WaPo)
  • Taking More Than One Vaccine at a Time Doesn't Hurt (NYTimes)

Regulatory Reconnaissance #443 – 18 November 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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