Regulatory Focus™ > News Articles > Regulatory Reconnaissance (10 June 2013)

Regulatory Reconnaissance (10 June 2013)

Posted 10 June 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Experimental Drug Saves Babies, but FDA Hurdle Remains (NBC) (NBC) (NBC)
  • Gilead Announces FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C (Gilead) (SCRIP) (MNT) (Pharma Times) (BioCentury) (Reuters)
  • FDA rejects Aveo kidney cancer drug, asks for additional trial (Reuters) (Aveo) (Fierce)
  • FDA asks for more safety data on Dynavax's hepatitis B vaccine (Reuters) (Dynavax)
  • FDA planning to issue LDT guidance, already under OMB review (BioCentury)
  • CMS Tougher on Devices than Drugs; Finding Could Challenge Parallel Review (FDA News)
  • Are Dietary Supplement Firms Underreporting AERs? (Natural Products Insider)

In Focus: International

  • Africa Prodded To Harmonize Drug Regulations Over Next 10 Years (PharmAsia News)
  • High-Ranking India Regulators To Inspect Two Ranbaxy Suspect Plants (PharmAsia News) (India Times)
  • Teva Withdraws Batches of the Diuretic Drug Furosemide Lasix After Patient Dies (ANSM) (ANSM)
  • EU approves new use of Roche's RoActemra in children (PMLive) (Roche) (Reuters) (Pharma Times)
  • IMDRF Plans Single-Audit International Pilot in 2014 (FDA News)
  • Developing nations to introduce resolution on access to medicines at UN Human Rights Council (PharmaBiz)

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

US

Pharmaceuticals/Biotechnology
  • Experimental Drug Saves Babies, but FDA Hurdle Remains (NBC) (NBC) (NBC)
  • Gilead Announces FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C (Gilead) (SCRIP) (MNT) (Pharma Times) (BioCentury) (Reuters)
  • GDUFA Facility Fees Likely To Increase Due To Fewer Self-IDs (Pink Sheet)
  • FDA rejects Aveo kidney cancer drug, asks for additional trial (Reuters) (Aveo) (Fierce)
  • FDA approves Sanofi Pasteur influenza vaccine (Reuters) (Sanofi)
  • FDA asks for more safety data on Dynavax's hepatitis B vaccine (Reuters) (Dynavax)
  • BioDelivery Sciences Announces NDA Submission for BUNAVAIL on Track Following Positive Pre-NDA Meeting with FDA (BioDelivery)
  • Reagan-Udall Post-Market Drug Surveillance Initiative Could Address Patient Web Sites (Pink Sheet)
  • Court ruling doesn't mean immediate access to morning after pills (AP)
  • PhRMA Statement on Sequestration of PDUFA User Fees (PhRMA)
  • A Milestone for Accelerated Approval: HIV No Longer Qualifies (RPM Report)
  • Breakthrough Designation Explained (Genentech)
  • New FDA Mapp: CDER Informatics Governance Process (FDA)
  • NanoViricides Submits DengueCide Orphan Drug Designation Application to the US FDA for Dengue and Dengue Hemorrhagic Fever (Business Wire)
  • The First Circuit joins the D.C. Circuit in hampering relators' ability to bring duplicative actions under the False Claims Act's first-to-file rule (BABC)
  • Patent attorney frets that Supreme Court gene-patenting case will end badly for drug companies (Philly Pharma)
  • FDA may soon require warning labels on sunscreen with low SPF to lower skin cancer threat (Med City News)
  • Can Roche Make A Case For Avastin In Brain Cancer Based On Quality Of Life? (Pink Sheet)
  • Compounding Industry Launches Campaign Against New Legislation (MyMedsMatter) (The Hill)
  • Bad Drug Reactions can be Detected by Data Mining Electronic Medical Records (MedIndia)
  • Drugs stored in ambulances can degrade faster than those kept refrigerated (Reuters)
  • Boehringer Ingelheim's investigational faldaprevir+ achieved viral cure in 88% of treatment-naïve hepatitis C patients in Asia (BI)
  • Oregon Governor signs legislation to create pathway for substitution of biologics (BioSimilar News)
  • Is Google helping online drug dealers? State attorneys general say yes (Med City News) (USA Today) (Law 360)
  • Latest Episode of BioCenturyTV: Patients Upend the Traditional Research Model (BioCenturyTV)
Medical Devices
  • FDA planning to issue LDT guidance, already under OMB review (BioCentury)
  • UDI Final Rule Takes Industry Advice, But Will Still Pose Challenges: Experts (FDA News)
  • Adverse Medical Device Events Involve Children Most, Study Shows (MDDI) (Fierce)
  • CMS Tougher on Devices than Drugs; Finding Could Challenge Parallel Review (FDA News)
  • An Online Labeling Repository? Device Firms Are Lukewarm At Best (Gray Sheet)
  • Can Smartphones Help Improve Access To Medications? (Brookings)
  • Exact Sciences Submits Final Module and Completes Cologuard Premarket Approval Application to FDA (Exact Sciences)
  • Class 1 Recall for EndoLogix's Catheter Introducer (FDA)
Assorted and Government
  • Open.FDA.Gov: Cloud-Based Initiative In The Works To House Public, Shared Data (Gray Sheet)
  • Are Dietary Supplement Firms Underreporting AERs? (Natural Products Insider)
  • Conflicting data on FDA's conflicts policy (BioCentury)
  • House Exceptionalizes FDA for FY 14 … But More Needed (Stronger FDA)
  • New Initiative to Turn Big Data into Insight (Eye for Pharma)
  • Animal-rights advocates sense turning point in chimpanzee research (The Hill)
  • Opinion: Don't Take Your Vitamins (NYTimes)
  • SCRIP's US Capitol Capsule (SCRIP)
Upcoming Meetings and Events
  • 11-12 June 2013: FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices (FDA)
  • 12-13 June 2013: 16th Annual FDA-OCRA Educational Conference (OCRA)
  • 13 June 2013: 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device (FDA)
  • 13 June 2013: Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • 14 June 2013: Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research (FDA)
  • 14 June 2013: Congressional Hearing on Prescription Drug Abuse (E&C)
  • 18 June 2013: Understanding the Regulatory Landscape for Adaptive Design Trials (RAPS)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

Europe

  • Teva Withdraws Batches of the Diuretic Drug Furosemide Lasix After Patient Dies (ANSM) (ANSM)
  • MHRA Issues Progress Report on Defective PIP Breast Implants (MHRA)
  • All minutes from the EUnetHTA/EMA meetings are now available (EUnetHTA)
  • EU approves new use of Roche's RoActemra in children (PMLive) (Roche) (Reuters) (Pharma Times)
  • Apricus Biosciences Receives European Approval for Vitaros(R) for the Treatment of Erectile Dysfunction (Apricus)
  • Ben Goldacre: No escape from trial transparency (PMLive)

Asia

Other International

  • IMDRF Plans Single-Audit International Pilot in 2014 (FDA News)
  • Developing nations to introduce resolution on access to medicines at UN Human Rights Council (PharmaBiz)
  • Africa Prodded To Harmonize Drug Regulations Over Next 10 Years (PharmAsia News)
  • Global alliance formed to create framework for genomic data sharing (Fierce)
  • Uganda grapples with critical blood shortage (IRIN)

General Regulatory and Interesting Articles

  • Fluoroquinolones and acute kidney injury (RPS)
  • Disruptive technologies: Advances that will transform life, business, and the global economy (E&Y)

Regulatory Reconnaissance #84 - 10 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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe