Regulatory Recon: Report Shows the Downsides to FDA's Surrogate Approvals (27 October 2014)

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

In Focus: US

• The Slippery Slope: Is a Surrogate Endpoint Evidence of Efficacy? (MedPage Today) (MedPage Today)
• FDA Orphan Approval Flexibility Remains Steady As Pressure Increases (Pink Sheet-$)
• Baxter wins FDA approval for another hemophilia drug (FDA) (Fierce) (Pharma Times) (Reuters) (MedPage Today) (Press)
• Novo Nordisk receives U.S. subpoena related to Danish Insulin factory (Mass Device) (Fierce) (Reuters)
• FDA Working to Create a "Patient Engagement Panel" for its Medical Device AdComm (FDA)
• FDA Wants More NDI Notifications (WholeFoods)

In Focus: International

• Ladislav Miko tipped as acting SANCO head, following chief resignation (NutraIngredients)
• Singapore HSA seeks feedback on regulations for pharmaceutical products (Channel NewsAsia)
• GPhA raises objections to TPP IP text (SCRIP-$)
• EMA encourages companies to submit quality type I variations for 2014 by end of November (EMA)
• Pharma must be consulted on companion Dx reg, EU Commission tells Parliament (Clinica-$)

US: Pharmaceuticals and Biotechnology

• The Slippery Slope: Is a Surrogate Endpoint Evidence of Efficacy? (MedPage Today) (MedPage Today)
• FDA Orphan Approval Flexibility Remains Steady As Pressure Increases (Pink Sheet-$)
• Baxter wins FDA approval for another hemophilia drug (FDA) (Fierce) (Pharma Times) (Reuters) (MedPage Today) (Press)
• Novo Nordisk receives U.S. subpoena related to Danish Insulin factory (Mass Device) (Fierce) (Reuters)
• Companies Fail to Scrutinize Data Integrity in Supplier Audits, Top FDA Official Says (FDA News-$)
• Ranbaxy might lose Nexium exclusivity (Business Standard)
• Six First to File Paragraph IV ANDAs Reported By OGD – But Where Are the Approvals? (Lachman)
• Kalydeco Label Expansion Could Set New Precedent On FDA Flexibility (Pink Sheet-$)
• The GS1 Healthcare US Guidance For DSCSA, Vs 1.1 (RxTrace)
• Reimbursement Shapes FDA Panel’s Dosing Decision For Novartis’ Il-17 Blocker (Pink Sheet-$)
• Are FDA and CE sacrificing safety for a faster commercialization of xenogeneic tissue devices? Unavoidable need for legislation in decellularized tissue manufacturing.  (PubMed)
• Expanded access – Myths, Truth and Behavior (PharmExec)
• Intravia Containers by Baxter: Recall - Particulate Matter (FDA) (FDA)
• Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: DIAMOX (Acetazolamide) Intravenous, 500 Milligrams Base/Vial, and DIAMOX (Acetazolamide) Tablets, 125 and 250 Milligrams (FDA)

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

• FDA Wants More Data on Sarepta's Eteplirsen NDA (Press) (CNBC) (Reuters)
• Complete Response Letter for Lundeck's Carbella NDA Over CMC Data (Pharma Letter-$) (Press)
• Merck Receives FDA Breakthrough Therapy Designation for KEYTRUDA (pembrolizumab) in Advanced Non-Small Cell Lung Cancer (FDA)
• Burzynski Research Institute, Inc. Announces FDA Permission to Launch a New Clinical Trial in Diffuse Intrinsic Brainstem Glioma (Press)

US: Pharmaceuticals and Biotechnology: General

• Hepatitis C Drug Head-To-Head Comparative Studies Debated At PCORI Workshop (Pink Sheet-$)
• Once 'market failure,' orphan drugs ripe for investing (SCRIP-$) (PharmExec)

US: Medical Devices

• FDA Working to Create a "Patient Engagement Panel" for its Medical Device AdComm (FDA)
• Medical Device Quality Planning (MDDI)
• Legacy Devices The Weak Link In Cybersecurity Fence (Gray Sheet-$)
• US FDA sees American dream for China high-risk devices (Clinica-$)
• FDA: Certain Auto-Injectors OK to Use 1 Year Beyond Exp Date (MPR)
• Class 1 Device Recall for Hospira's GemStar Medical Power Supply (FDA)
• St. Jude Medical Receives FDA Approval of TactiCath Quartz Contact Force Ablation Catheter for Treatment of Atrial Fibrillation (Press)

US: Dietary Supplements

• FDA Wants More NDI Notifications (WholeFoods)
• Fabricant Predicts Possible 2015 Regulatory Activity (WholeFoods)
• FDA Says Big Firms Meeting GMP Regs (NPI)
• Understanding Comparative Claims (NPI)

US: Assorted And Government

• FDA Can’t Just Pare Back Without Risk for Harm (Strengthen FDA)
• 4 Things To Watch As FDA Flexes New Inspection Powers (Law 360-$)

Upcoming Meetings

• RAPS' FDA Scientific Advisory Committee Meeting Tracker

Ebola Outbreak

• Five More Ebola Vaccines To Be Tested in March (AP)
• Ebola Treatments Could Be Orphan Candidates – But Vaccines, Probably Not (Pink Sheet-$)
• EU boost for GSK's Ebola vaccine research (PMLive)

Europe

• Ladislav Miko tipped as acting SANCO head, following chief resignation (NutraIngredients)
• EMA encourages companies to submit quality type I variations for 2014 by end of November (EMA)
• Pharma must be consulted on companion Dx reg, EU Commission tells Parliament (Clinica-$)
• EU Pharmaceutical Industry Supports Trademark Counterfeit Reforms, Seeks Some Modifications (FDA News-$)
• NICE's Value-Based Assessment delay - the analyst's view (Pharma Times)
• Superbug-driven surge in polymyxin demand prompts EMA to reassess safety info (In-Pharma)
• Changes to scientific advice procedures as of 17 November 2014 (EMA)
• All referral procedures to be sent via eSubmission Gateway / Web Client from 1 November 2014 (EMA)
• EU consortium to combat antibiotic resistance (PharmaPhorum)
• Patients help Clinuvel win CHMP recommendation for orphan Scenesse (SCRIP-$)
• Industry voice: In defense of nutritional medical devices in the EU (NutraIngredients)
• Guidance on the assessment of persistent, bioaccumulative and toxic or very persistent and very bioaccumulative substances in veterinary medicine (EMA)

India

• Insight On India – Highlights From The Week Of Oct 19-25, 2014 (TwoFourInsight)
• India's Department of Industrial Policy and Promotion creates IPR Think Tank to Draft National IPR Policy (KEI)
• UPFDA to recruit drug inspectors after a gap of 5 years following HC ruling (PharmaBiz)
• Cipla's Hamied voices continued support for Indian compulsory licenses (SCRIP-$)

China

• Biosimilars in China: The coming revolution (BioPharmaDive)
• Development of Taiwan's strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations (PubMed)

Canada

• Pharma Fails to Keep R&D Spending Commitment to Canada (Pharmalot)

Australia

• Trans-Pacific Partnership taking shape behind closed doors, Andrew Robb says (Guardian)

Other International

• Singapore HSA seeks feedback on regulations for pharmaceutical products (Channel NewsAsia)
• GPhA raises objections to TPP IP text (SCRIP-$)
• Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products (AAPS)

Clinical Trials

• Six Ways Social Media Affects Your Clinical Trial (whether you like it or not) (RareDR)
• Adaptive Trials Are Here… Are You Ready? (Geeks Talk Clinical)
• Stem Cell Agency Invests $24 Million To Create Alpha Clinic Network (CIRM)

General Regulatory And Interesting Articles

• 3D printing may make individualized medicine more affordable (MDT)
• Corneal Implants Might Make Reading Glasses Obsolete (NPR)
• The Most Reprehensible Black Market: Malaria Drugs (Slate)

Regulatory Reconnaissance #427 – 27 October 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.