Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves First-Ever 3D Printed Drug (4 August 2015)

Regulatory Recon: FDA Approves First-Ever 3D Printed Drug (4 August 2015)

Posted 04 August 2015 | By Michael Mezher 

Regulatory Recon: FDA Approves First-Ever 3D Printed Drug (4 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

  • How to identify a device throughout its lifecycle? IMDRF calls for comment (Clinica-$)
  • MHRA Enforces EC Decision to Suspend Medicines Studied at GVK Biosciences (MHRA)
  • CFDA Proposes Sweeping Action on Approvals, Poor Quality Submissions (PharmAsiaNews)
  • China FDA wants signed internal audits on clinical trial applications this month (FiercePharmaAsia)
  • Australia looks to speed clinical trial start-up times (Outsourcing-Pharma)
  • OraSure gets FDA nod for emergency use of rapid Ebola test (FierceDiagnostics)
  • Is the Ebola vaccine 100% effective? (Healthcare Economist)
  • Biologic patent life emerges as sticking point in failed TPP talks (BioPharma Dive) (Politico) (FiercePharmaAsia)
  • Singapore HSA Proposes New Medical Device and IVD Grouping Criteria (MassDevice)

Sponsored Content:

With the implementation of the 2011 Food Safety Modernization Act (FSMA), the landscape of food safety regulation is undergoing extensive changes.  While the food industry is responding to FSMA, it is not always clear what is necessary for full compliance as new rules and regulations unfold. Learn more about what Johns Hopkins University is doing to educate food industry leaders about these new regulations. Click here to read the full article.

US: Pharmaceuticals and Biotechnology

  • First-Ever 3D Printed Drug Approved by FDA (Reuters) (medGadget) (Forbes) (Press)
  • Ready for the Big Biomarker Debate? (SCRIP-$)        
  • FDA veteran questions science behind antibiotics fast track (In-Pharma Technologist)
  • FDA Discloses FY 2016 Drug User Fee Rates (SCRIP-$)
  • RICO Suits Challenge Off-Label Drug Marketing (Law360-$)

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

  • Clovis Oncology files for rociletinib approval in USA and Europe (PharmaLetter-$) (BioCentury)
  • Lexicon and Ipsen's telotristat etiprate Phase III trial meets primary endpoint (PharmaLetter-$) (SCRIP-$)
  • US FDA approves Bayer's Finacea (PharmaLetter-$)
  • New Chlamydia Vaccine Uses Synthetic Biology (DD&D)
  • Oasmia Pharma posts positive top-line results for its cancer drug (PharmaLetter-$)
  • FDA accepts Mundipharma EDO’s IND for EDO-S101 (European Pharmaceutical Review)
  • New 'drug-entrapped' artificial blood vessels stay clot-free (MNT)
  • Vaccine With Virus-Like Nanoparticles is Effective Treatment for RSV (ICT)

US: Pharmaceuticals and Biotechnology: General

  • Opposing Views on FDA Complete Response Letters (MedCityNews)
  • FDA Targeting GDUFA Fee Scofflaws Again With Letters (Pink Sheet-$)
  • Regulatory Planning for FDA FY 2016 (FDA Atty)
  • FDA Basics Metrics: July 2015 (FDA)

US: Medical Devices

  • Serious Infections From Scopes Go Beyond Duodenoscopes (LA Times) (LA Times) (FierceMedicalDevices) (MedCityNews)
  • 510(k)s Should Benefit From Adult-To-Peds Extrapolation Too, AdvaMed Says (Gray Sheet-$)
  • OraSure gets FDA nod for emergency use of rapid Ebola test (FierceDiagnostics)
  • How to identify a device throughout its lifecycle? IMDRF calls for comment (Clinica-$)
  • Cook Medical Issues Global Recall of Beacon Tip Angiographic Catheter Products (Press) (FDA)
  • Lawsuit Tells How Politics Trump FDA’s “Gold Standard” (MDDI)
  • TAVI: Study finds low stroke rates with Medtronic’s CoreValve (MassDevice)
  • Army scientists roll out innovative blood loss monitor device (FierceMedicalDevices)
  • FDA Reclassifies Trichomonas Vaginalis and External Upper Esophageal Sphincter Compression Device to Class II (FDA) (FDA)
  • Medical Device Decision Plays PA’s Greatest Hits (Drug and Device Law)
  • Medical Devices and Patient Safety Concern (MedCityNews)
  • Emergent launches in-licensed military-grade autoinjector outside the US, aims for FDA approval (FierceMedicalDevices)
  • Trends in Drug-Delivery Devices (MDDI)
  • Ulthera nabs FDA nod for cellulite treatment, to launch in the fall (FierceMedicalDevices)
  • Top Reimbursement Tips for Medical Device Makers (MDDI)
  • PhysIQ Personalized Physiology Analytics Engine Software Receives First FDA Clearance (Press)
  • NuVasive Inc. Agrees to $13.5 Million False Claims Act Settlement (Policy and Medicine)

US: Assorted and Government

  • Sequestration Budgeting Threatens FDA Programs, OMB Tells Senate (Gray Sheet-$)
  • Lawsuit Accuses CVS of Overcharging for Generic Drugs (DD&D)
  • Eli Lilly faces first U.S. trials over Cymbalta withdrawal (Reuters)

Upcoming Meetings and Events

Europe

  • MHRA Enforces EC Decision to Suspend Medicines Studied at GVK Biosciences (MHRA)
  • Expanded EU Approval for Roche's Perjeta In Early Stage Breast Cancer (SCRIP-$)
  • ICH guideline M8 on eCTD – questions and answers (EMA)
  • ICH Q3C (R6): Impurities: guideline for residual solvents (EMA)
  • ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients (EMA)
  • Guideline for good clinical practice E6(R2) (EMA)
  • GSK's Synflorix Gains Positive Opinion from CHMP for Label Extension (DD&D)
  • Application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes (EMA)
  • Soligenix Receives Orphan Designation from the EC for SGX301 for Cutaneous T-Cell Lymphoma (Press)
  • Clovis Oncology files for rociletinib approval in USA and Europe (PharmaLetter-$) (BioCentury)
  • HUMIRA approved by EC for moderate to severe hidradenitis suppurativa (MNT)

India

  • Ajanta Pharma gets USFDA nod for generic asthma treatment drug (Economic Times)

China

  • CFDA Proposes Sweeping Action on Approvals, Poor Quality Submissions (PharmAsiaNews)
  • China FDA wants signed internal audits on clinical trial applications this month (FiercePharmaAsia)
  • BeiGene gets CFDA approval to conduct clinical trial (BioCentury)
  • Bribery, Sex Tapes and Political Intrigue, GSK Rehires Former Exec Linked to China Scandal (BioSpace)

Japan

  • Merck eyes opportunity for omarigliptin filing with Japan's PMDA (FiercePharmaAsia)
  • Shionogi’s constipation medicine proves effective in trials (BioSpectrum)

Australia

  • Australia looks to speed clinical trial start-up times (Outsourcing-Pharma)
  • Contact Detach infusion sets recall (TGA)

Ebola Outbreak

Other International

  • Ex-Teva employee said she got canned for passing info to the feds in Latin America fraud probe (FiercePharma)
  • TPP is Still Alive but Prognosis is Iffy at Best (Forbes)
  • Biologic patent life emerges as sticking point in failed TPP talks (BioPharma Dive) (Politico) (FiercePharmaAsia)
  • Singapore HSA Proposes New Medical Device and IVD Grouping Criteria (MassDevice)
  • How to identify a device throughout its lifecycle? IMDRF calls for comment (Clinica-$)
  • Korean companies lag behind in new drug research (BioSpectrum)

General Health and Interesting Articles

  • The Failure of Jessica Alba's Honest Company Sunscreen Explained (Forbes)
  • Feds Call for More Scrutiny of Nursing Home Errors Involving Blood Thinner (ProPublica)
  • Snail Venom Yields Potent Painkiller, but Delivering the Drug is Tricky (NPR)
  • The device kept him alive, but was the pain and suffering worth it? (Washington Post)

Regulatory Reconnaissance #610– 4 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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe