Regulatory Focus™ > News Articles > Regulatory Recon: FDA Can't Stop 'Truthful' Off-Label Promotion in First Amendment Ruling (10 August

Regulatory Recon: FDA Can't Stop 'Truthful' Off-Label Promotion in First Amendment Ruling (10 August 2015)

Posted 10 August 2015 | By Michael Mezher 

Regulatory Recon: FDA Can't Stop 'Truthful' Off-Label Promotion in First Amendment Ruling (10 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

In Focus: International

  • Europe: the new frontier for precision medicine (PharmaPhorum)
  • IQWiG finds hint of non-quantifiable added benefit for Jakavi in polycythemia vera (PharmaLetter-$)
  • EFPIA Welcomes EU/Vietnam Trade Deal That 'Goes Beyond TRIPS' (SCRIP-$)
  • Not Just A Tweak: UK Review Seeks Sea Change in Drug Development (SCRIP-$)
  • IMI research world class, report reveals (EFPIA)
  • Ebola Survivors Face Lingering Pain, Fatigue and Depression (NYTimes)

US: Pharmaceuticals and Biotechnology

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

  • The Little Pink Pill: Awaiting "Pink Viagra" Approval (Press)
  • Celgene 'Waives Claims' Of Psoriasis Drug Otezla's Added Benefit (SCRIP-$)
  • Upsher-Smith Receives FDA Approval For Generic Version Of Namenda Tablets (Press)
  • FDA Approves Taro’s Keveyis (dichlorphenamide) 50 mg Tablets for Primary Hyperkalemic and Hypokalemic Periodic Paralysis (Press)
  • Gliknik Licensee Pfizer Receives Orphan Drug Designation From FDA for Drug Candidate Directed Towards Rare Neurological Disorder (Press)
  • Gamida Cell Achieves Major Regulatory Milestone: FDA and EMA Respond Positively to NiCord® Phase III Study Design Outline (Press)
  • Extension Study Data Supporting Long-Term Safety and Efficacy of Eloctate® Published in Haemophilia (Press)

US: Pharmaceuticals and Biotechnology: General

  • Oral History of Drug Development: FDA’s Califf Wants Woodcock, Temple to Share Their Stories (Pink Sheet-$)
  • Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide, Dies at 101 (NYTimes) (SCRIP-$) (NPR)
  • Thalidomide, Drug Marketing And FDA Oversight (Forbes)
  • Podcast: FDA To Launch New Knowledge-Sharing Platform For Next-Gen Sequencing (Gray Sheet-$)
  • Honest Co. Sunscreen Failure Triggers 'Natural' Debate, FDA Criticism (Tan Sheet-$)
  • Why Haven't Rates of Dangerous Co-Prescribing Dropped? (MPR)
  • Op-Ed: No Surprise in FDA Side Effect Reporting Delays (MedpageToday)

US: Medical Devices

  • Further Deconstruction of the Law in Pelvic Mesh (Drug and Device Law)
  • US FDA staff can act with discretion under revised refuse-to-accept 510(k) policy (Clinica-$)
  • FDA: Cook beacon tip angio cath recall is Class I (MassDevice) (FDA)
  • Class 1 Device Recall ReSTOR IOL (FDA)
  • The Regulatory Challenges of Obtaining 510(k) Clearance for Devices with Antibiotics (MDDI)
  • How Best to Change FDA's Combination Product Regs? (MDDI)
  • FDAVoice: Need a guidance document? We’ve got you covered (MassDevice)
  • Leksell Gamma Knife Icon Brain Radiosurgery System FDA Cleared (medGadget) (MassDevice)
  • X-Ray Exposure to Fetus Not Linked to Harmful Effects, Study Finds (MPR)
  • Samsung win FDA 510(k) for digital radiography system (MassDevice)
  • App to identify pain based on facial analysis under development (FierceMedicalDevices)
  • Nanoparticles Penetrate Mucus Barrier to Bring Gene Therapy to Lung Parenchyma (medGadget)
  • Stryker gets FDA nod to use Mako robot for total knee reconstruction (FierceMedicalDevices)

US: Assorted and Government

  • Members of Congress Call on GAO to Investigate Surgical Tool (WSJ-$)
  • Concerns about FDA IT security persist, House committee report says (In-Pharma Technologist)
  • US Capitol Capsule: Washington's Drug Policy Game: JnJ's Jay Siegel's A Player (SCRIP-$)
  • Actavis gets subpoena as DOJ probe of generic pricing moves up food chain (FiercePharma)

Upcoming Meetings and Events                                                            

Europe

  • Europe: the new frontier for precision medicine (PharmaPhorum)
  • IQWiG finds hint of non-quantifiable added benefit for Jakavi in polycythemia vera (PharmaLetter-$)
  • EFPIA Welcomes EU/Vietnam Trade Deal That 'Goes Beyond TRIPS' (SCRIP-$)
  • Not Just A Tweak: UK Review Seeks Sea Change in Drug Development (SCRIP-$)
  • IMI research world class, report reveals (EFPIA)

Canada

  • Health Canada Approves the Glaukos iStent inject (Press)

Japan

  • ALK’s Japanese partner reports positive results for hay fever drug (BioSpectrum)

China

Ebola Outbreak

  • Ebola Survivors Face Lingering Pain, Fatigue and Depression (NYTimes)
  • College students still largely misinformed about Ebola (Reuters)

Other International

General Health and Other Interesting Articles

  • Deadly infections from medical scopes go unreported, raising health risks (USA Today)

Regulatory Reconnaissance #614– 10 August 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 @Michael_Mezher 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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