Regulatory Reconnaissance (2 October 2013)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. We're coming to you from Boston this week for the 2013 RAPS Regulatory Convergence-our annual gathering of thousands of regulatory professionals. If you see us walking around, come say "Hello"! We'd love to meet you. In the meantime, got any tips or gripes? Shoot us an email at [email protected].

In Focus: US

• House Shutdown Battle Could Go On For Weeks (AP) (SCRIP-$)
• FDA to continue pre-shutdown reviews (but not new ones, and not on biosimilars) (BioCentury) (Pink Sheet-$) (PharmExec)
• Could a Shutdown Impact the US's Status Under New EU API Rules? (Outsourcing Pharma)
• Changes Proposed to Add HSCs to Definition of "Human Organ" (DHHS)
• Congress Moves Closer on Compounding Bill (MedPage Today)
• FDA Will Allow ANDA Corrections … Until 10 Minor Deficiencies Found (Pink Sheet-$)
• Pelvic mesh makers look to settle lawsuits (Mass Device)

In Focus: International

• EU launches black triangle drug monitoring scheme (PMLive)
• Public consultation on the publication and access to clinical-trial data now closed (EMA)
• Draft reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product (EMA)
• Concept paper on the development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tract (EMA)
• SmPCs contribute little to effective use of medicines (RPS)

Comments? Suggestions? Email me at [email protected].

US: Pharmaceuticals/Biotechnology

• FDA to continue pre-shutdown reviews (but not new ones, and not on biosimilars) (BioCentury) (Pink Sheet-$) (PharmExec)
• CVM Notification of Industry of Impacts of the Shutdown (FDA)
• Could a Shutdown Impact the US's Status Under New EU API Rules? (Outsourcing Pharma)
• Changes Proposed to Add HSCs to Definition of "Human Organ" (DHHS)
• Culture Clash: FDA Tries to Re-Educate Indian Firms on Processes and Accurate Reporting (RPM Report-$)
• Ranbaxy may shift key drug filings from Mohali to US (India Times)
• Congress Moves Closer on Compounding Bill (MedPage Today)
• Despite FDA shutdown, Gilead, Amarin still on for high-profile panels (Fierce)
• Salix and Progenics Announce FDA Advisory Committee Scheduled to Review Relistor sNDA for Opioid-Induced Constipation in Patients with Chronic Pain (Press)
• FDA Will Allow ANDA Corrections … Until 10 Minor Deficiencies Found (Pink Sheet-$)
• Warning Letter Sent to Company Over Failure to Pay GDUFA Fees and Failure to Register (FDA)
• FDA Withdrawing Approval For Some Toxic Animal Feed Drugs (Law 360-$) (NYTimes)
• 505(b)(2) NDA RLD and Impurities Explained in Petition Response (FDA Lawyers Blog)
• Anacor Pharmaceuticals Announces FDA Acceptance of Tavaborole NDA for Filing (Press) (BioCentury)
• US court lifts ban on relative to AZ's Nexium (Pharma Times) (AZ)
• Vaccines and Related Biological Products Advisory Committee; Notice of Meeting (FDA)
• New Bill Would Perpetuate FDA-State Compounding Confusion (Law 360-$)
• Wright Pushes FTC For More Pay-For-Delay Study (Law 360-$)
• FDLI 2013: Insights in Enforcement, Litigation & Compliance for Pharmaceutical and Medical Device Manufacturers (Policy and Medicine)

US: Pharmaceuticals and Biotechnology: General

• Pharma Trade Group Seeks To Stop HHS Orphan Drug Rule (Law 360-$)

US: Medical Devices

• Medtronic Minimed Gets Warning Letter From FDA for 21 CFR 820 Deficiencies (FDA)
• Pelvic mesh makers look to settle lawsuits (Mass Device)
• Class 1 Recall for H&H Medical's Cuff Calloon Due to Structural Weakness (FDA)
• Cerus Submits the First of Three Modules in the Premarket Approval (PMA) Application Process for INTERCEPT Platelets (Press)
• Afikim Electric Vehicles Issues Nationwide Recall Of Breeze C Scooter: Recall - Potential For Malfunction (FDA)
• Nucletron, an Elekta Company, Receives US FDA 510(k) Clearance for Esteya Electronic Brachytherapy System for Treating Skin Cancer (Press)

US: Assorted And Government

• House Shutdown Battle Could Go On For Weeks (AP) (SCRIP-$)
• Obama to feds: 'None of this is fair to you' (Federal Times)
• Members propose paying federal workers hit by government shutdown (The Hill)
• Top 10 Ways Supplement Companies Get a Warning Letter (NPI)

Upcoming Meetings And Events

• 29 Sept. - 2 Oct. 2013: 2013 RAPS Regulatory Convergence (RAPS)
• 3 October 2013: Congressional Hearing on FDA's Implementation of FDASIA (E&C) (POSTPONED)
• 4 October 2013: Joint FDA-EMA Orphan Drug Workship (Details)
• October 8-9, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
• 9-10 October 2013: AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings (AAMI)
• Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

• EU launches black triangle drug monitoring scheme (PMLive)
• Public consultation on the publication and access to clinical-trial data now closed (EMA)
• Draft reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product (EMA)
• Concept paper on the development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tract (EMA)
• Changes to European medical device regulations will not protect patients with diabetes and a central European Device Agency is needed, says EASD (MNT)
• SmPCs contribute little to effective use of medicines (RPS)
• Surprise! Unannounced notified body audits Commission recommendation finally issued (MediicalDevicesLegal)
• GE's Latest Vivid E9 Ultrasound System Gains CE Mark Approval (MedGadget)

Asia

• South Korea Suspends Sales Of Pfizer Antibiotic For Labeling Problems (PharmAsia-$)

Other International

• Russia restricts food supplement marketing (Nutra-Ingredients)

General Regulatory And Interesting Articles

• Study of Hormone Use in Menopause Reaffirms Complex Mix of Risks and Benefits (NYTimes)
• The Pill's link to depression still unclear (Reuters)

Regulatory Reconnaissance #169 - 2 October 2013

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.

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Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at [email protected].