Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Releases New eCTD Validation Specifications (14 February 2014)

Regulatory Reconnaissance: FDA Releases New eCTD Validation Specifications (14 February 2014)

Posted 14 February 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • FDA Releases New eCTD Validation Specifications (FDA)
  • Bayer says FDA rejects wider use of Xarelto drug (Reuters)
  • 'More than 2,000' US lawsuits for Boehringer over Pradaxa Risks (Pharmafile) (Law 360-$) (Fierce)
  • FDA to Hold Meeting on Implementation of National and International Medical Device Registries (FDA)
  • Vendors aren't interested in cybersecurity, medtech hacker says (Mass Device)
  • Warning letter to Exclusive Supplements shows NDI enforcement here to stay, experts say (Nutra-Ingredients)

In Focus: International

  • EU Parliament Releases Marked-up Report on Pharmacovigilance Fees (EP)
  • Concept paper on the need for a single note for guidance on the chemistry of active substances (EMA)
  • EMA to expand orphan drug HTA collaboration (PMLive)
  • Where do you start? Nine regulatory knots the EU has to unravel (Clinica-$)
  • EU Pharma Denies Skirting Rules On Pediatric Cancer Drug Development (Pink Sheet-$)

US: Pharmaceuticals/Biotechnology

  • FDA Releases New eCTD Validation Specifications (FDA)
  • Bayer says FDA rejects wider use of Xarelto drug (Reuters)
  • 'More than 2,000' US lawsuits for Boehringer over Pradaxa Risks (Pharmafile) (Law 360-$) (Fierce)
  • Four Companies Kept Out Of GPhA Discussions On State Biosimilar Strategy (IHP-$)
  • Cubist Tedizolid Advisory Cmte. Review Will Gauge FDA's Mood On Antibiotic "Breakpoints" (Pink Sheet-$)
  • FDA to discuss Cubist, Durata ABSSSI products (BioCentury)
  • New FDA Guide on Off-Label Use of Drugs in Animals (FDA)
  • Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health. (FDA)

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

  • Pfizer, AstraZeneca aim for Gout Treatment Approvals in 2014 (Bloomberg)

US: Pharmaceuticals and Biotechnology: General

  • DOJ prosecutor: is there a way to secure APIs from counterfeiters? (In-Pharma)
  • Suit Over Missouri Execution Drug Draws Scrutiny (AP) (AP)
  • Accused counterfeit Rx drug smugglers arraigned in US court (SCRIP-$) (PharmPro) (FDA)
  • Is U.S. Health Care More Expensive? (NCPA)
  • Colorado Kids Get Legal Pot as New York Doctors Can Barely Study It (The Street)

US: Medical Devices

  • FDA to Hold Meeting on Implementation of National and International Medical Device Registries (FDA)
  • Vendors aren't interested in cybersecurity, medtech hacker says (Mass Device)
  • When a University Hospital Backs a Surgical Robot, Controversy Ensues (ProPublica)
  • Building the case against Apple developing a medical device (MobiHealthNews)
  • Blood Purification Technologies gets FDA green light for artificial kidney trials (Fierce)
  • IMRIS receives FDA clearance for next generation VISIUS Surgical Theatre (Press)
  • JustRight Surgical wins FDA clearance for first ever 5mm classic surgical stapler (Press)
  • U.S. FDA Grants 510(k) Clearance To Innovative Device For Easy Medication Administration When Patients Are Unable To Swallow (Press)

US: Dietary Supplements

  • Warning letter to Exclusive Supplements shows NDI enforcement here to stay, experts say (Nutra-Ingredients)
  • FDA warns consumers of possible health risks and dietary supplement use (WCPO)

US: Assorted And Government

Upcoming Meetings And Events

  • 12 February 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 13 February 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 14 February 2014: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU Parliament Releases Marked-up Report on Pharmacovigilance Fees (EP)
  • Concept paper on the need for a single note for guidance on the chemistry of active substances (EMA)
  • EMA to expand orphan drug HTA collaboration (PMLive)
  • Where do you start? Nine regulatory knots the EU has to unravel (Clinica-$)
  • EU Pharma Denies Skirting Rules On Pediatric Cancer Drug Development (Pink Sheet-$)
  • Work plan for GMP/GDP Inspectors Working Group for 2014 (EMA)
  • Tryton Medical lands added EU stent clearance (Mass Device)
  • EU Lifts Duties On Chinese Pharma Chemical Imports (Law 360-$)
  • Is the breast cancer drug tamoxifen being sold as a bodybuilding dietary supplement? (BMJ) (PJOnline)
  • Ketamine to become a class B drug (PJOnline)

Japan & China

  • Novartis in spotlight again over Japan study practices (SCRIP-$)

Other International

  • Russia Drug-Control Agency Urges Easier Painkiller Access At Local Level (PharmAsia-$)

General Regulatory And Interesting Articles

  • Pharma's reputation stays low in 2013 (PMLive) (SCRIP-$)

Regulatory Reconnaissance #257 - 14 February 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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