Regulatory Recon: Australia Announces Major Change in Device Regulation Policies (15 October 2014)

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

In Focus: US

• FDA reviewers advise against dropping Chantix black box (SCRIP-$) (Tarius) (AP) (Pink Sheet-$) (Fierce) (Pharmalot) (Reuters)
• FDA Commissioner in Philadelphia, says drug approval process is making progress (BizJournal)
• The Trouble With Antibiotics (FrontLine) (Reuters)
• Biosimilar Policy Update: Extrapolation Looks Like Default Approach (RPM Report-$)
• Replaceable Urinary Prosthesis For Women Cleared by FDA (MPR) (FDA) (Medscape)
• Class III Device Recalls An Afterthought? Not So Fast . . . (Silver Sheet-$)
• FDA to Hold Workshop on Diabetes Management Software (FDA)
• Fine print of GMP compliance still a mystery to many small manufacturers, expert says (NI-USA)

In Focus: International

• Australian manufacturers of medical devices given a level playing field (TGA) (Press)
• European Commission abandons plan to transfer control of pharma products to Industry Commissioner (PharmaLetter-$) (EurActiv)
• In UK, Designated pharmacist to review procedures for trials of cancer drugs (Pharm Journal)
• Indian drugmakers scramble to prevent shortages of HIV/AIDS meds (Fierce)
• NICE bars Celgene's Imnovid from NHS funding (PharmaTimes) (BioCentury) (PharmaPhorum)
• WHO slams pharma for failing to invest in 'non-profitable' Ebola R&D (BioPharma-Reporter)

US: Pharmaceuticals and Biotechnology

• FDA reviewers advise against dropping Chantix black box (SCRIP-$) (Tarius) (AP) (Pink Sheet-$) (Fierce) (Pharmalot) (Reuters)
• FDA Commissioner in Philadelphia, says drug approval process is making progress (BizJournal)
• The Trouble With Antibiotics (FrontLine) (Reuters)
• Biosimilar Policy Update: Extrapolation Looks Like Default Approach (RPM Report-$)
• AAP Chimes in on Pediatric Exclusivity and Whether a Written Request is a Condition Precedent to FDA Awarding Exclusivity (FDA Law Blog)
• From “Safe Harbor” To Spotlight: Pharmacogenomics Comes Of Age At FDA (RPM Report-$)
• Federal judge approves FDA consent decree with Ascend Laboratories (FDA)
• U.S. top court hears Teva's multiple sclerosis drug patent fight (Reuters)
• Patient-Focused Drug Development Initiative at FDA hits mid-way mark (FasterCures)
• FDA Approves Expanded Use of Navidea’s Lymphoseek for Lymphatic Mapping in Solid Tumors (Press)
• Bracco Diagnostics Inc. Receives U.S. FDA Approval for New Ultrasound Contrast Agent (Press)
• FDA Helps Tackle Sickle Cell Disease (FDA)
• Hospira Announces Voluntary Nationwide Recall Of Certain Lots Of Several Lifecare Products Due To Potential For Leakage (FDA)

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

• U.S. FDA Grants Priority Review Status to NDA for Anticancer Agent Lenvatinib (Press) (BioCentury)
• FDA Grants Eisai's sNDA for Rufinamide Priority Review as Adjunctive Treatment in Pediatric Patients Ages 1-4 for Seizures Associated with Lennox-Gastaut Syndrome (Press)
• GW Pharma's cannabis-based drug comes up short in ulcerative colitis (Fierce)
• INC Research Signs Agreement to Perform FDA Due Diligence Audit of Regulatory Documents for Provectus Biopharmaceuticals (Press)

US: Pharmaceuticals and Biotechnology: General

• If AbbVie Discounts its Hep C Drug, Would Pricing Reach a Tipping Point? (Pharmalot)
• A Drug Regrew A Little Girl's Missing Bones. How Much Should That Cost? (Forbes)
• Cure for Alzheimer's Disease: Cost or Value? (RPM Report-$)

US: Medical Devices

• Replaceable Urinary Prosthesis For Women Cleared by FDA (MPR) (FDA) (Medscape)
• Class III Device Recalls An Afterthought? Not So Fast . . . (Silver Sheet-$)
• FDA to Hold Workshop on Diabetes Management Software (FDA)
• Specialized Device Inspectorate Part Of Joint CDRH/ORA Action Plan (Silver Sheet-$)
• New enterovirus D68 lab test gets faster results (ModernHealthcare) (Reuters) (CDC)
• Medtronic Announces FDA Approval of Pacing Lead for Full-Body MRI Scans (Press) (Mass Device)
• Covidien Issues Field Safety Alert for Defibrillation Electrodes due to Connection Issues (FDA) (FDA)
• Clinical Innovations Announces FDA Approval of Koala Toco, an Advanced Technology Tocodynamometer (Press)
• Medtronic Launches U.S. Trial For Predictive Glucose Monitor-Pump System (Gray Sheet-$)

US: Dietary Supplements

• Fine print of GMP compliance still a mystery to many small manufacturers, expert says (NI-USA)

US: Assorted And Government

• Satire: FDA Approves Depressant Drug for the Annonyingly Cheerful (The Onion)
• FDA’s giant NMR magnet puts more imaging power into our regulatory science (FDA)

Upcoming Meetings

• RAPS' FDA Scientific Advisory Committee Meeting Tracker

Ebola Outbreak

• WHO slams pharma for failing to invest in 'non-profitable' Ebola R&D (BioPharma-Reporter)
• Ebola Volunteers Are Needed — But Signing On Isn't Easy (NPR)
• NIH Ebola Update: Working Toward Treatments and Vaccines (NIH)
• Dallas nurse with Ebola gets blood from survivor (ModernHealthcare)
• Why Aren't More Ebola Victims Receiving Donated Convalescent Serum? (NBC)
• Second Texas healthcare worker tests positive for Ebola (Reuters) (NPR)

Europe

• European Commission abandons plan to transfer control of pharma products to Industry Commissioner (PharmaLetter-$) (EurActiv)
• EMA open to discuss use of complementary methodologies for rare cancers (Press)
• NICE bars Celgene's Imnovid from NHS funding (PharmaTimes) (BioCentury) (PharmaPhorum)
• AstraZeneca looks to EU decision for next cancer drug boost (Reuters)
• EDQM issues draft guidelines on endotoxins, pyrogens & sterile products, seeks comments from industry (PharmaBiz)
• NICE urged over biologic drugs for ulcerative colitis (PharmaTimes)

India

• Indian drugmakers scramble to prevent shortages of HIV/AIDS meds (Fierce)

Japan

• Alexion Submits NDA in Japan for Asfotase Alfa as a Treatment for Patients with Hypophosphatasia (Press)

Australia

• Australian manufacturers of medical devices given a level playing field (TGA) (Press)

Clinical Trials

• In UK, Designated pharmacist to review procedures for trials of cancer drugs (Pharm Journal)

General Regulatory And Interesting Articles

• Smart Bandage Warns of Wound-Healing Problems (SciAm)
• Allergy To Orthopedic Metals Linked To Cancer (MedDeviceOnline)

Regulatory Reconnaissance #421 – 15 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].

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