Regulatory Recon: One Last News Roundup Before we Go on Holiday (19 December 2014)

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

This is the final Regulatory Reconnaissance of 2014. Your editor will be back on 5 January 2015 with a roundup of all the news he missed during his two-week holiday. Suffering from regulatory news withdrawal? Check out this handy list of ways you can stay on top of regulatory intelligence in our absence.

As always, thank you for your continued readership—there were almost 300,000 pageviews for Regulatory Recon in 2014!—and we'll see you early in 2015.

In Focus: US

• FDA: We Hope to be Able to Receive eCTD Module 1 v2.3 by Q3 2015 (FDA)
• Janet Woodcock on CDER Priorities (FDA)
• OPDP slams print ad in Untitled Letter (MM&M) (FDA) (FDA) (Law 360-$)
• Advertising Enforcement Actions Decline to Lowest Point in Five Years (FDAnews-$)
• Industry Expresses Trepidations With Proposed Pill Change Survey (FDAnews-$)
• Vascular Solutions Fights Criminal Misbranding Charges In Vari-Lase Case (Gray Sheet-$)
• FDA to Industry: Prepare for GUDID (FDA)
• FDA Says Herbalife Video Misleading (Natural Products Insider) (FDA) (Tan Sheet-$)

In Focus: International

• GSK Ebola vaccine trial seen moving to wider phase in February (Reuters)
• EMA's CHMP Recommends 7 New Medicines for Approval (EMA)
• First stem-cell therapy recommended for approval in EU (EMA)
• Orexigen diet pill recommended for approval in Europe (Reuters) (Press) (EMA)
• Philippine health minister resigns over vaccine purchase (Reuters)

US: Pharmaceuticals and Biotechnology

• FDA: We Hope to be Able to Receive eCTD Module 1 v2.3 by Q3 2015 (FDA)
• Janet Woodcock on CDER Priorities (FDA)
• OPDP slams print ad in Untitled Letter (MM&M) (FDA) (FDA) (Law 360-$)
• Advertising Enforcement Actions Decline to Lowest Point in Five Years (FDAnews-$)
• FDA/Generic Communications Plan Restoring Best Of Past Practices (Pink Sheet-$)
• FDA is Sued Over the Applicability of 3-Year Exclusivity in the Context of Dueling Tacrolimus NDAs; Agency Gets a Short Reprieve to Make a Final Decision (FDA Law Blog)
• Industry Expresses Trepidations With Proposed Pill Change Survey (FDAnews-$)
• FDA’s Janet Woodcock, M.D., recognized by the Institute for Safe Medication Practices: Receives Lifetime Achievement Award for her career in public service (FDA)
• Regulatory science needs for neonates: a call for neonatal community collaboration and innovation (PubMed)
• Laser 3D Printing with Sub-Microscale Resolution of Porous Elastomeric Scaffolds for Supporting Human Bone Stem Cells (PubMed)
• Teva Announces FDA Approval of QNASL (Beclomethasone Dipropionate) Nasal Aerosol for Treatment of Children with Seasonal and Perennial Allergic Rhinitis (Press)
• Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs (PubMed)
• DEA Adds Three Canabanoids to Schedule I (DEA)
• Cytori and BARDA Amend Contract Option to Accelerate the Advancement of a Thermal Burn Injury Countermeasure (Press)

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

• Double blow for Roche as Alzheimer's, breast cancer studies fail (Reuters) (Press) (Press) (Fierce)
• Translarna Granted Orphan Drug Designation in the U.S. and Europe for the Treatment of Mucopolysaccharidosis I (Press)
• Polaris Group receives orphan drug designation for ADI-PEG 20 from the FDA (PharmaLetter-$)

US: Pharmaceuticals and Biotechnology: General

• What would an FDA OK on AbbVie's hep C cocktail mean for payers? (Fierce)
• Painkillers Lawsuit Against NFL Dismissed (AP)

US: Medical Devices

• Vascular Solutions Fights Criminal Misbranding Charges In Vari-Lase Case (Gray Sheet-$)
• FDA to Industry: Prepare for GUDID (FDA)
• Sorin wins FDA nod for Memo3d ReChord mitral annuloplasty ring (Mass Device)
• Bio2 Technologies, Inc. Announces Receipt of FDA 510(k) Clearance for CLM Bioactive Scaffold (Press)
• The U.S. Regulates 21st Century Health Technology Under A Law Signed By Gerald Ford (Forbes) (Article also omits most of the definition of medical device)

US: Dietary Supplements

• FDA Says Herbalife Video Misleading (Natural Products Insider) (FDA) (Tan Sheet-$)
• Supplement Maker Lied About Ingredients (AP) (NI-USA)
• Codex Alimentarius Commission: Meeting of the Codex Committee on Methods of Analysis and Sampling (FSIS)

US: Assorted And Government

• Enforcement Report - Week of December 17, 2014 (FDA)

Upcoming Meetings

• RAPS' FDA Advisory Committee Meeting Tracker
• 5 Critical Biotech Drug Dates and Events for December (24/7 Wall Street)

Ebola Outbreak

• GSK Ebola vaccine trial seen moving to wider phase in February (Reuters)
• WHO: Some NIAID/GSK Ebola vaccine efficacy trials delayed (SCRIP-$)
• One More Drug For Ebola Treatment Pipeline? (NBC) (Bloomberg)
• Q&A: Ebola pioneer looks to the future of drug development (PharmJournal)
• SPR Advanced Technologies Receives Funding From USAID To Deploy Innovative Solution To Combat Ebola Epidemic (Press)

Europe

• EMA's CHMP Recommends 7 New Medicines for Approval (EMA)
• First stem-cell therapy recommended for approval in EU (EMA)
• Orexigen diet pill recommended for approval in Europe (Reuters) (Press) (EMA)
• Novo Nordisk gets positive opinion on Tresiba for children in Europe (Reuters)
• New RAPS Netherlands Chapter Announced (Regulatory Focus)
• Celgene Receives Positive CHMP Opinion to Extend REVLIMID (Lenalidomide) for Continuous Use in Patients with Newly Diagnosed Multiple Myeloma and Ineligible for Transplant (Press)
• European Regulator Finds Problematic Pay-to-Delay Deals at a ‘Low Level’ (Pharmalot)
• Loopholes in the new policy on publishing clinical study reports from the European Medicines Agency need to be closed (PharmJournal)
• Translarna Granted Orphan Drug Designation in the U.S. and Europe for the Treatment of Mucopolysaccharidosis I (Press)

India

• India warns Egypt companies against selling Sovaldi medicines (India Times)
• India's trial regulations choking academic research (SCRIP-$)

Australia

• IVD term development handover to GMDN Agency (TGA)
• Australia finally gives cystic fibrosis patients access to Kalydeco (PharmaPhorum)

Other International

• Philippine health minister resigns over vaccine purchase (Reuters)
• All change for medical devices in Russia – but just how quickly? (Clinica-$)
• PHARMAC Stressing Biosimilar Use For Savings (PharmAsia-$)

Clinical Trials

• Consensus Report of a Joint NCI Thoracic Malignancies Steering Committee: FDA Workshop on Strategies for Integrating Biomarkers into Clinical Development of New Therapies for Lung Cancer Leading to the Inception of "Master Protocols" in Lung Cancer (PubMed)
• WIL IT software deal speed up US FDA drug evaluations? Yes says Instem (Outsourcing Pharma)

General Regulatory And Interesting Articles

• Basics: Documenting a Real QMS (MasterControl)
• PhRMA Report on the 25-Year Fight Against Hepatitis C (PhRMA-PDF)
• Worries About Unusual Botulinum Toxin Prove Unfounded (NPR)

Regulatory Reconnaissance #463 – 19 December 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 [email protected].

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.