Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Post-Thanksgiving Edition (2 December 2013)

Regulatory Reconnaissance: Post-Thanksgiving Edition (2 December 2013)

Posted 02 December 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. This special edition covers everything you might have missed over the Thanksgiving holiday. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

In Focus: International

  • Guidance for companies to be developed after EMA and HTAs share views (Pharma Letter-$) (EMA)
  • Phased-in approach to implementing EU Falsified Medicines Directive recommended; report (Pharma Letter-$)
  • EU Risk Plan Easing For Long-Marketed Products Sought By Industry Groups (Pink Sheet-$)
  • AHWP Report: The Forseeable Harmonization Horizon (AHWP)
  • AHWP Forms New Working Group on Standards (AHWP)
  • India's CDSCO to have staff strength of 5000 in next 5 years, recruitment plan submitted to centre (PharmaBiz)
  • The Current Global Medical Device Regulatory Environment (MDDI)
  • Thalidomide class action settled in Melbourne for $89m (Guardian) (Bloomberg)

US: Pharmaceuticals/Biotechnology

  • Drug compounding, tracking bill signed into U.S. law (Reuters) (SCRIP-$) (AP) (White House) (The Hill) (Alexander) (Upton) (BioCentury) (HELP Cmte) (Securing Industry) (RxTrace) (In-Pharma Tech) (Pink Sheet-$)
  • FDA Enters Into Consent Decree; Agrees to Timely Complete Triclosan OTC Drug Antiseptic Monographs (FDA Law Blog)
  • FDA committee to discuss Epi proColon 2.0 (BioCentury)
  • DEA Places Fycompa (Perampanel) into Schedule III (DEA)
  • Intermediate Endpoint Proposals For Cancer Immunotherapies Don't Sway FDA (Pink Sheet-$)
  • Expanded Access Opens Window For Dose Optimization Studies In Cancer (Pink Sheet-$)
  • FDA denies making a promise on opioids (MM&M)
  • GDUFA Comment Period Extended (FDA)
  • FDA's Temple: Better Meta-Analyses Needed Ahead Of Agency Guidance (Pink Sheet-$)
  • FDA's Pazdur Highlights Need For Unbiased Toxicity Assessments (Pink Sheet-$)
  • White House Pushes 12-Year Exclusivity For Biologics In Trade Talks (Pharmalot) (USTR)
  • VBL Therapeutics Receives FDA Fast Track Designation for Lead Compound VB-111 (Press)
  • Baxter recalls nitroglycerin in 5% Dextrose Injection in US (BioSpectrum) (FDA) (FDA)
  • FDA study helps provide an understanding of rising rates of whooping cough and response to vaccination (FDA)
  • Expanded Access Opens Window For Dose Optimization Studies In Cancer (Pink Sheet-$)
  • Warning Letter to IRB Lists Littany of Problems (FDA)
  • FDA Polled Review Staff On Avandia REMS Changes (Pink Sheet-$)
  • Avandia Reviewers Weigh In (Pink Sheet-$)
  • "Real-World" Breo Study: A Q&A With GSK's David Leather (Pink Sheet-$)
  • Latest National Nanotechnology Initiative Strategic Plan Released for Comment (FDA Law Blog)
  • Biogen Idec Receives Notification from FDA of PDUFA Date Extension for ALPROLIX (Press)
  • DMC recommends halt to Actelion's macitentan Ph III study in digital ulcers (Pharma Letter-$)
  • FDA releases Three 483s sent to meridian Medical Technologies (FDA)
  • Novo to launch mid-stage tests with new diabetes pill (Reuters)
  • Words Of Wisdom For Biosimilar Developers (RPM Report-$)
  • GPhA Requests Extension of Comment Period on Proposed Labeling Rule (Lachman)
  • Wockhardt revenues may dip up to $250 m on USFDA ban (India Times)
  • Zalviso New Drug Application Accepted for Filing by FDA (Press)
  • New PREA Noncompliance Letter Sent to Purdue Pharma (FDA)
  • Jubilant receives FDA approval for antipsychotic drug (India Times)
  • AstraZeneca, Ranbaxy Can't Ax Claims In Nexium Antitrust MDL (Law 360-$)
  • Bioniche Life Sciences Inc. Horse Product Approved for Sale in the U.S. (Press)
  • One Drug, Two Names, Many Problems (NYTimes)
  • Family Of 12-Year-Old New Hampshire Girl Seeks FDA Exception For Cancer Drug (NHPR)

US: Pharmaceuticals and Biotechnology: General

  • AMP Final Rule Delayed Yet Again ... to May 2014 (Drug Channels)
  • Theraclone setback as BARDA says no to flu MAb (SCRIP-$) (Press) (Fierce)
  • Ohio Oncologist Sentenced To Probation For Importing Non-FDA Approved Cancer Drugs (Safe Medicines)

US: Medical Devices

  • Physicians Report Alarming Increase In LVAD Pump Thrombosis (Forbes) (NEJM) (Reuters) (Forbes) (Cardiovascular Business)
  • Questions Remain On Incorporating UDIs Into Health Care System (Gray Sheet-$)
  • Early Registry Outcomes Suggest TAVR Roll-Out Has Been Successful So Far (Gray Sheet-$)
  • Why The FDA Can't Be Flexible With 23andMe, By Law (Forbes)
  • Why 23andMe might have the FDA worried: It gave me a false diagnosis (Quartz)
  • 23andMe digs in as FDA demands tests come off the market (Fierce)
  • Abbott Issues Voluntary Recall of Certain FreeStyle and FreeStyle Lite Blood Glucose Test Strips in the United States (FDA) (FDA) (Fierce)
  • Claret Medical Announces Filing Of US Pivotal IDE Application For The Sentinel Cerebral Protection System (Press)
  • Sumitomo Proton Therapy System Clears FDA 510(k) (Press)
  • Elekta receives US FDA 510(k) clearance for its Monaco 5 treatment planning system (Press)

US: Dietary Supplements

US: Assorted And Government

  • Change to the Definition of Human Organ under the National Organ Transplant Act (HRSA)
  • E-mails show cozy relationship between Obama trade negotiators and pharma, device and biotech industry groups (Washington Post)
  • Patent Bill Aims For Trolls, But Will It Snare Rx Firms Instead? (Pink Sheet-$)
  • Generic Manufacturers May Gain Edge In New Patent Challenge Procedure At PTO (Pink Sheet-$)
  • Sequester in 2014 will be worse, report warns (Federal Times)
  • At many agencies, fears of an exodus (The Hill)
  • Enforcement Report - Week of November 27, 2013 (FDA)
  • SCRIP's US Capitol Capsule (SCRIP-$)

Upcoming Meetings And Events

  • 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)
  • 11 December 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 11-12 December 2013: Allergenic Products Advisory Committee Meeting (FDA)
  • 12 December 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Guidance for companies to be developed after EMA and HTAs share views (Pharma Letter-$) (EMA)
  • Phased-in approach to implementing EU Falsified Medicines Directive recommended; report (Pharma Letter-$)
  • EU Risk Plan Easing For Long-Marketed Products Sought By Industry Groups (Pink Sheet-$)
  • Renewed version of the HTA Core Model available (EUnetHTA)
  • Who gets paid for what? Slow progress on EU PV fees (SCRIP-$) 
  • EU rethinks regulation (Pharmafile)
  • Regulatory information - adjustment of linguistic review timetable for opinions adopted at December CHMP meeting (EMA)
  • Industry, stakeholders push on EU trial times (Pharma Times)
  • CHMP recommends GSK's two-dose Cervarix (SCRIP-$) (Press) (PMLive) (Pharma Times)
  • Got a combination product? 4 top tips to avoid the regulatory pitfalls (Clinica-$)
  • How registering all trials will make a difference to transparency (AllTrials)
  • A harmonized EU approach to combination products regulation: elusive, but much needed (Clinica-$)
  • NICE wants more rifaximin data for hepatic encephalopathy (BioCentury) (Pharma Times) (Pink Sheet-$)
  • pSivida Reports ILUVIEN to Be Funded by UK's National Health Service for Treatment of Pseudophakic Chronic DME Patients Following Issuance of Final NICE Guidance (Press)
  • Celgene's Abraxane gets positive CHMP opinion for pancreatic cancer (Pharma Letter-$)
  • Pre-AMNOG drugs wriggle off Germany's retrospective assessment hook, but no escape for Novartis (SCRIP-$) 
  • UK govt launches DNA mapping competition (Pharma Times) (UK Gov)

Asia

  • AHWP Report: The Forseeable Harmonization Horizon (AHWP)
  • AHWP Forms New Working Group on Standards (AHWP)
  • AHWP: "Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Ex-change" (AHWP)
  • India's CDSCO to have staff strength of 5000 in next 5 years, recruitment plan submitted to centre (PharmaBiz)
  • India: Court Stays DCGI Order on Submission of Safety Data of Fixed Drug Combinations (PharmaBiz)
  • Bayer files VEGF Trap-Eye for myopic choroidal neovascularization in Japan (Pharma Letter-$) (Press)
  • Eisai Submits Application For Proton Pump Inhibitor Pariet In Japan (Press)
  • Russian Parliament to take tough stand over counterfeit drugs (Pharma Letter-$)

Other International

  • The Global Medical Device Regulatory Environment (MDDI)
  • One in five South African health care centers experience ARV stock shortages (Pharma Letter-$) (Reuters)
  • Thalidomide class action settled in Melbourne for $89m (Guardian) (Bloomberg)

General Regulatory And Interesting Articles

  • Study links high sodium 'fizzy' medicines to raised heart risks (Reuters) (Pharma Times)
  • Opioid over-regulation can leave cancer patients in intolerable pain (Reuters) (Pharma Times)
  • Linking Genes to Diseases by Sifting Through Electronic Medical Records (NYTimes)
  • Contagious Diseases in the United States from 1888 to the Present (NEJM) (MedPage Today)
  • Dandruff Shampoo Could Mess Up Waterways (Scientific American)
  • Bringing Back My Real Self With Hormones (NYTimes)
  • Lick-to-Taste and Taste Over IP: The Beginning of an Era of Virtual Tasting? (MedGadget)
  • 3D printing's oddest application yet: Cheaper, better prosthetic eyes (MedCity News)
  • Sex, Lies and HIV: When What You Don't Tell Your Partner Is a Crime (ProPublica)

Regulatory Reconnaissance #212 - 2 December 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 news@raps.org.


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