Regulatory Focus™ > News Articles > Regulatory Reconnaissance (19 June 2013)

Regulatory Reconnaissance (19 June 2013)

Posted 19 June 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • UDI Rule Due out Next Week: FDA Source (MDDI)
  • After two deaths, FDA investigates Lilly schizophrenia drug (FDA) (FDA) (Reuters) (Fierce) (IBJ) (BioFlash) (Pharmalot) (MedPage Today) (Market Watch) (SCRIP) (BioCentury) (Pink Sheet)
  • FDA has collected more than $255 million in generic drug user fees, nearing $299 million goal (DSN)
  • Investor-backed thinktank calls for changes to drug funding and approval (Reuters)
  • GSK Settles Charges That it Files Bogus Citizen Petitions to Delay Competition, Will Pay $150M (LexisNexis)
  • FDA User Fees Could Be Freed From Sequester As Senate Drafts Bill (Pink Sheet)
  • FDA to get $2.552 Billion Under FY2014 Senate Appropriations Funding Bill (Senate)
  • Is It Time To Overhaul The FDA? (Pharmalot)

In Focus: International

  • U.K. relents on July deadline for API certifications (In-Pharma Technologist) (Fierce)
  • Lundbeck Fined $125.6 Million by EU Drug Delay Probe (Bloomberg) (NYTimes)
  • More accurate self-testing results for diabetes patients with new ISO standard (ISO)
  • EMA's PRAC drafting public hearing rules (BioCentury)
  • Class 1 Recall for Gilead's AmBisome Powder for Solution for Infusion Due to Lack of Sterility Assurance (MHRA)
  • Trans-Pacific Partnership Pact Set As Test Ground For Getting Biologics Data Exclusivity At National Levels (PharmAsia)
  • Japan Ministry Still Puzzled By Adverse HPV Vaccine Reactions (PharmAsia)
  • GSK recalls Ventolin from around the world over glass particle risk (Fierce) (In-Pharma Technologist)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • After two deaths, FDA investigates Lilly schizophrenia drug (FDA) (FDA) (Reuters) (Fierce) (IBJ) (BioFlash) (Pharmalot) (MedPage Today) (Market Watch) (SCRIP) (BioCentury)
  • Zyprexa Relprevv REMS May Need Revision Following Two Patient Deaths (Pink Sheet)
  • FDA has collected more than $255 million in generic drug user fees, nearing $299 million goal (DSN)
  • Investor-backed thinktank calls for changes to drug funding and approval (Reuters)
  • GSK recalls Ventolin from around the world over glass particle risk (Fierce) (In-Pharma Technologist)
  • GSK Settles Charges That it Files Bogus Citizen Petitions to Delay Competition, Will Pay $150M (LexisNexis)
  • FDA committee to discuss Otsuka's tolvaptan (BioCentury) (FDA)
  • Glenmark gets FDA approval for sclerosis treatment drug (India Times)
  • PhRMA To Assist Pay-For-Locate Trial Enrollment Tool To Boost Study Diversity (Pink Sheet)
  • OGD 'Attack' Team Reviewing Supplements for Shorted Drugs (FDA News)
  • FDA Submits Orphan Drug Regulation Changes to OMB for Approval (OIRA)
  • Altaire Pharmaceuticals Submits Citizen Petition to FDA to Approve Generic of Bausch + Lomb's Gentamicin Sulfate Ophthalmic Solution (FDA)
  • FDA Approves Efficacy Supplements for Hospira's NDA for Precedex (#021038) (FDA)
  • Adamas claims success with new and improved Parkinson's drug (Fierce) (SCRIP)
  • FDA accepts NDA for RedHill/IntelGenx oral thin film migraine drug (SCRIP) (BioCentury)
  • Vanda's Sleep Disorder Drug Is A Nightmare (The Street)
  • AstraZeneca, Bristol diabetes drug disappoints in key test (Reuters) (Business Wire) (Fierce) (Guardian)
  • Diet products contain dangerous drugs, FDA warns (NBC)
  • New group will push lawmakers for drug compounding safety (Kanas City Star) (The Tennessean)
  • U.S. court finds Novo Nordisk Prandin diabetes drug patent invalid (Reuters)
  • With a Top Secret Letter, HRSA Blesses Amgen's New 340B Distribution Plan (Drug Channels)
  • PEPFAR Celebrates 10 Year Anniversary (Engel)
Medical Devices
  • UDI Rule Due out Next Week: FDA Source (MDDI)
  • 40,000 health-related apps and no easy way to know which ones work (MedCity News)
  • Medtronic, Researchers See Infuse Open-Access Project As Model For The Future (Gray Sheet)
  • FDA Wants to Reclassify Intra-Aortic Balloon and Control Systems (IABP) as Class II Devices (FDA)
  • Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis (FDA)
  • FDA Isn't Prepared to Deal with Digital Health, Cybersecurity (MDDI)
  • Endologix endures FDA deadly warning over recall (Fierce) (FDA) (FDA)
  • Boston Scientific targets FDA with brain-stim trial (Fierce)
  • Oversight and Investigations Subcommittee Continues Investigation of BioWatch and Surveillance of Bioterrorism (House)
Assorted and Government
  • FDA User Fees Could Be Freed From Sequester As Senate Drafts Bill (Pink Sheet)
  • Is It Time To Overhaul The FDA? (Pharmalot)
  • FDA to get $2.552 Billion Under FY2014 Senate Appropriations Funding Bill (Senate)
  • Organs Should be Screened for Additional Diseases, Government Recommends (WSJ)
  • Vaccine advocate takes on the alternative medicine industry (NBC)
  • The Intersection of Medical Technology and the CIA (Federal Times)
  • New Batch of FDA Warning Letters Posted (FDA)
  • Groups want guidance on ACA provision requiring coverage of trial expenses (BioCentury)
  • Survey of Nanomaterial Risk Management Practices (CDC)
  • Bernard Munos on The Last Twelve Years of Pharma (In the Pipeline)
  • A.M.A. Recognizes Obesity as a Disease (NYTimes) (NBC)
  • Return of the Regulatory Accountability Act: A Veiled Threat to Public Protections (CFEG)
  • Skyrocketing doxy price gouging shows further action needed (SCRIP)
Upcoming Meetings and Events
  • 17 June 2013: FDA Basics Webinar: Biological Products: Part 1 (FDA)
  • 18 June 2013: Understanding the Regulatory Landscape for Adaptive Design Trials (RAPS)
  • 18 June: NCATS to announce awards for Discovering New Therapeutic Uses for Existing Molecules program (NCATS)
  • 18 June 2013: Continuing Concerns Over BioWatch and the Surveillance of Bioterrorism (House)
  • 18 June 2013: Appropriations Committee Hearing on FDA (Senate)
  • 19-20 June 2013: Regulatory Education for Industry (REdI) Conference (FDA)
  • 21 June 2013: Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting (FDA)
  • 24 June 2013: Science Board Meeting (FDA)
  • 25 June 2013: Meeting of the National Biodefense Science Board (DHHS)
  • 25-26 June 2013: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 26 June 2013: General and Plastic Surgery Devices Panel of the Medical Devices Meeting (FDA)
  • 27 July 2013: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

Europe

  • U.K. relents on July deadline for API certifications (In-Pharma Technologist) (Fierce)
  • Lundbeck Fined $125.6 Million by EU Drug Delay Probe (Bloomberg) (NYTimes)
  • EMA's PRAC drafting public hearing rules (BioCentury)
  • European Medicines Agency revises MUMS / limited-market policy (EMA)
  • Class 1 Recall for Gilead's AmBisome Powder for Solution for Infusion Due to Lack of Sterility Assurance (MHRA)
  • Ipsen reports mixed Ph III results with Somatuline Autogel in patients with acromegaly (Pharma Letter)
  • Agenda for Upcoming SCENIHR Meeting (EC)
  • Committee for Medicinal Products for Veterinary Use re-elects Dr Anja Holm as chair (EMA)

Asia

  • Trans-Pacific Partnership Pact Set As Test Ground For Getting Biologics Data Exclusivity At National Levels (PharmAsia)
  • Japan Ministry Still Puzzled By Adverse HPV Vaccine Reactions (PharmAsia)
  • India's Drug price control formula leaves companies shaky, cos approach pharma department (India Times)
  • Daiichi Sankyo files NDA for Prasugrel in Japan  (BioSpectrum)

Other International

  • More accurate self-testing results for diabetes patients with new ISO standard (ISO)
  • Brazil Plans Own Making Of H1N1 Vaccine To Avoid Private-Sector Pitfalls (PharmAsia)
  • Australia's TGA Unveils New Mobile-Friendly Website (TGA)

General Regulatory and Interesting Articles

Regulatory Reconnaissance #91 - 19 June 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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