Regulatory Focus™ > News Articles > Regulatory Reconnaissance (28 August 2013)

Regulatory Reconnaissance (28 August 2013)

Posted 28 August 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • US approvals on track for another impressive year (EP Vantage)
  • Lifting the Veil on FDA Subpart H Surrogate Endpoint Approvals (FDA Law Blog)
  • FDA's IRB Guidance Impinges On Sponsor And CRO Terrain, Industry Says (Pink Sheet)
  • Antibiotics working group wants two approval pathways (BioCentury)
  • Set the FDA mobile medical app guidance free! (Mobi Health News)
  • DePuy Hip Implant Attorneys Call For FDA Investigation (Law 360)
  • The dynamic evolution of multi-sponsor REMS (Pharma Commerce)

In Focus: International

  • India to have dedicated devices regulators (Clinica)
  • What will the Intermune and Abbvie cases mean for the medical devices industry? (MedDevices Legal)
  • Imminent deadline for experts to work on EU/China devices manual (Clinica)
  • Eisai drug gets first WHO prequalification for a neglected tropical disease (SCRIP)

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

US

Pharmaceuticals/Biotechnology
  • US approvals on track for another impressive year (EP Vantage)
  • Lifting the Veil on FDA Subpart H Surrogate Endpoint Approvals (FDA Law Blog)
  • FDA's IRB Guidance Impinges On Sponsor And CRO Terrain, Industry Says (Pink Sheet)
  • FDA Makes Minor Correction in User Fee Notice (FDA)
  • Tiny Catalyst soars after rare disease drug scores 'breakthrough' at FDA (Fierce) (SCRIP)
  • Orexigen planning Contrave NDA resubmission by year end (BioCentury)
  • Antibiotics working group wants two approval pathways (BioCentury)
  • FDA's Creation Of Pharmacologic Classes Is Mostly Reviewers' Responsibility (Pharma Approvals Monthly)
  • FDA Used Invokana Review To Reflect On Diabetes CV Risk Policy (Pharma Approvals Monthly) (PAM)
  • FDA Accepts Boehringer Ingelheim's Supplemental New Drug Application for Use of Dabigatran Etexilate Mesylate in Deep Vein Thrombosis and Pulmonary Embolism (BI)
  • Public Citizen, Doctors Without Borders Hit Proposed Trade Deal's Treatment of Pharmaceutical Patent Protection (NYTimes)
  • Amarin asks FDA to approve Novasep as Vascepa partner (Fierce) (In-Pharma)
  • Auxilium Receives Notification of Xiaflex PDUFA Extension (Auxilium)
  • QRxPharma To Complete Refiling Of MOXDUO NDA In Q4 2013 (RTT)
  • NIH: Gilead's sofosbuvir cures some of the toughest hepatitis C cases (Fierce) (NIH)
  • Innovators on verge of winning California battle over biosimilar switches (SCRIP)
  • Takeda continues Actos resurrection as Alzheimer's drug (PMLive)
  • FDA Approves ANDA for Novast Labs' Generic Loestrin 24 FE, Larin FE 1/20 (FDA)
Pharmaceuticals: General
  • CMS Suspends Medicaid NARP Drug Data Collection (HIWW)
Medical Devices
  • Set the FDA mobile medical app guidance free! (Mobi Health News)
  • DePuy Hip Implant Attorneys Call For FDA Investigation (Law 360)
  • CDRH Seeking Training on Cardiac Electrophysiology and Ablation (FDA)
  • HeartWare Receives FDA Approval To Enroll Supplemental Patient Cohort In Destination Therapy Trial (HeartWare)
  • Wet Platinum Personal Lubricant Receives FDA 510(k) Medical Device Approval from Food and Drug Administration (PR)
  • InVivo stock plunges on trial delay for spine injury treatment (BioFlash)
Assorted And Government
  • New Batch of FDA Warning Letters Posted (FDA)
  • The dynamic evolution of multi-sponsor REMS (Pharma Commerce)
  • 21 CFR Part 11 Compliance Roadmap (Metric Stream)
  • Making Weight Management Supplements Sexy Without Irking the FDA (NPI)
  • White House Publishes Final Regulations For Obamacare's Individual Mandate (Forbes) (Health Affairs)
  • ECRI automates system to help hospitals respond to medical product recalls faster (Med City News)
  • Oregon Physicians Fined for Not Disclosing Relationships with Industry to Patients (Policy and Medicine)
  • Better Reporting of Scientific Studies: Why It Matters (PLoS)
Upcoming Meetings And Events
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • 4-5 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • What will the Intermune and Abbvie cases mean for the medical devices industry? (MedDevices Legal)
  • Imminent deadline for experts to work on EU/China devices manual (Clinica)
  • Allied granted CE mark for lead regenerative product CardioCel (MNT)
  • CE Mark approval for Seralite announced, the world's first point-of-care diagnostic device for multiple myeloma (MNT)

Asia

  • India to have dedicated devices regulators (Clinica)
  • Bangladesh Drug Makers Urge Making Nation Bioequivalence Test Center (PharmAsia)
  • Pakistan Regulators Approve 15% Increase in Drug Prices (PharmAsia)
  • DCGI allows cos to submit applications for FDCs at zonal or sub zonal offices before Aug 31 (PharmaBiz)

Other International

  • Health Canada Approves First Treatment for Advanced Forms of Common Cancer (PharmPro)
  • Eisai drug gets first WHO prequalification for a neglected tropical disease (SCRIP)

General Regulatory And Interesting Articles

  • Can toxicity of a DNA drug be predicted and minimized? (EurekAlert)

Regulatory Reconnaissance #141  - 28 August 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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