Regulatory Reconnaissance (1 November 2013)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: [email protected].

In Focus: US

• Novo to start releasing clinical study reports (BioCentury)
• FDA Includes Biologics In Proposed Shortage Early Notification Rule (IHP-$)
• Biosimilarity's Name of Thrones: Where are my DragINNs? (FDA Law Blog)
• New FDA Web Course Explains the Medical Device Single Audit Program (FDA)
• Hiring Strong for Regulatory Affairs Professionals in MedTech (MedDeviceSummit)
• Did FDA Shed Light on the Meaning of "Market Withdrawal" in the Updated RPM? Unfortunately, No. (FDA Law Blog)

In Focus: International

• EU Phrmacovigilance Amendments Come into Effect (EMA)
• Lack of US FDA biosimilars guidance not holding back global dev say EMA meeting attendees (BioPharma Reporter)
• China tightens clinical trial application rule for high-risk devices (Clinica-$)
• Third Study Of Novartis Valsartan Drug Found With Questionable Data (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

• Novo to start releasing clinical study reports (BioCentury)
• FDA Includes Biologics In Proposed Shortage Early Notification Rule (IHP-$)
• Biosimilarity's Name of Thrones: Where are my DragINNs? (FDA Law Blog)
• FDA approves label changes for anti-seizure drug Potiga (ezogabine) describing risk of retinal abnormalities, potential vision loss, and skin discoloration (FDA)
• Can Iclusig Return To Market? Ariad Sees Path Through Restricted Distribution REMS (Pink Sheet-$)
• FDA committees to discuss vedolizumab, metreleptin (BioCentury)
• USP Plans Standards on Good Distribution Practices (Biopharm International)
• AARP Seeks Reduced Data Exclusivity Period in TPP (Patent Docs)
• Impax Labs, Tolmar receive FDA approval for generic version of Solaraze (DSN)
• Ranbaxy Sues Actavis To Block Generic Absorica Acne Drug (Law 360-$)

US: Pharmaceuticals and Biotechnology: General

• Foreign cancer-drug dealer gets prison (Fierce)
• Are Farm Veterinarians Pushing Too Many Antibiotics? (NPR)

US: Medical Devices

• New FDA Web Course Explains the Medical Device Single Audit Program (FDA)
• Hiring Strong for Regulatory Affairs Professionals in MedTech (MedDeviceSummit)
• Did FDA Shed Light on the Meaning of "Market Withdrawal" in the Updated RPM? Unfortunately, No. (FDA Law Blog)
• Judge Invalidates Patent for a Down Syndrome Test (NYTimes)
• Reverse Medical lands CE Mark, 510(k) for brain catheters (Mass Device)
• Endochoice Receives FDA Clearance for Fuse 1G Gastroscope (MedGadget) (MedCity News)
• Class 1 Recall: Edwards Lifesciences EMBOLX Glide Protection System (FDA)
• Pentax Medical Company Issues Voluntary Nationwide Recall of OF-B194 Gas/ Water Valve (FDA)
• Acadia Pharmaceuticals Announces Publication in The Lancet of Pivotal Phase III Parkinson's Disease Psychosis Trial with Pimavanserin (Press)

US: Dietary Supplements

• CRN Submits Comments on Medical Food Guidance (NPI)
• Durbin sends USPLabs letter about OxyElite Pro liver injury issues (NutraIngredients)

US: Assorted And Government

• Enforcement Report - Week of October 30, 2013 (FDA)

Upcoming Meetings And Events

• 1 November 2013: Blood Products Advisory Committee Meeting  (FDA)
• 4-5 November 2013: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting (FDA) (Day 2)
• 5 November 2013: Hamburg Attending Bloomberg Innovation Event (BGov)
• 8 November 2013: Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
• 13 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
• 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
• 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
• 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
• 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
• 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
• 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
• Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

• EU Phrmacovigilance Amendments Come into Effect (EMA)
• Lack of US FDA biosimilars guidance not holding back global dev say EMA meeting attendees (BioPharma Reporter)
• EGA requests EMA to adopt revised biosimilars guideline rapidly (Biosimilar News) (Pharma Letter-$)
• National report based on pilot assessment of a vaccine using the HTA Core Model published (EUnetHTA)
• Baxter Submits Application for European Approval of RIXUBIS, Recombinant Factor IX (Nonacog Gamma) for Hemophilia B (Press) (BioCentury)
• AngioDynamics Gets CE Mark for AngioVac Venous Drainage Cannula (MedGadget)

Asia

• China tightens clinical trial application rule for high-risk devices (Clinica-$)
• New medical device regulation to boost innovation in India: Experts (PharmaBiz)
• Third Study Of Novartis Valsartan Drug Found With Questionable Data (PharmAsia-$)
• Celltrion Gears Up For Phase III Trial For Biosimilar Of Roche's Rituxan (PharmAsia-$)
• China: RDPAC Says Fees To Gather Phase IV Clinical Data Not Bribes (PharmAsia-$)
• Aricept filed for Lewy body dementia in Japan (SCRIP-$)

Regulatory Reconnaissance #193 - 1 November 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.

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 [email protected].