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

Regulatory Reconnaissance (19 August 2013)

Posted 19 August 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • FDA Ready To Hire New Deputy Commissioner For Medical Products And Tobacco (Pink Sheet)
  • AdvaMed Challenges Legality Of FDA Data Transparency Efforts (IHP)
  • FDA to Ranbaxy: We Intend to Issue Guidance on use of REMS by Generic Competitors (FDA Lawyers Blog)
  • GSK gets OK for second quadrivalent flu vaccine in US (PMLive) (Fierce) (GSK) (RTT) (Pharma Letter)
  • Public health advocates seeing red over delay in sunscreen products (The Hill)
  • FDA Awareness Letters Have Impact, Allergan Counsel Says (Law 360)
  • FDA says working with Merck, USDA on cattle drug Zilmax (Reuters)
  • Amid cattle health concerns, Merck halts Zilmax sales (Reuters) (WSJ) (Merck) (SCRIP) (Bloomberg)
  • Lawmakers: Accelerated Approval Guide Omits FDASIA Rare Disease Mandate (IHP)
  • FDA Calling For More PMAs Than 510(k)s In Final Set Of Preamendment Devices (Gray Sheet)

In Focus: International

  • How Will the EU Regulate Devices Products Intended to Enhance Human Function Instead of Correct Defecits? (Medical Devices Legal)
  • EU expands license for GSK's Tyverb (Pharma Times)
  • Cipla Chairman Urges India CL For Drugs Bound For Undeveloped Markets (PharmAsia) (Economic Times)
  • India To Push Through 26 New Drugs Without Gov't Approval (Forbes) (PharmAsia)
  • Indian Parliament Debates Roles of Regulatory Bodies in Controlling Pharmaceutical Sector (PharmaBiz)
  • Silver Lining: Will GSK Case Increase Compliance In China? (PharmAsia)
  • China: life sciences regulatory crackdown spreads to medical device sector (Lexology)
  • China FDA Highlights Product Recalls, Urges Manufacturers To Respond Rapidly (Gray Sheet)

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

US

Pharmaceuticals/Biotechnology
  • FDA to Ranbaxy: We Intend to Issue Guidance on use of REMS by Generic Competitors (FDA Lawyers Blog)
  • GSK gets OK for second quadrivalent flu vaccine in US (PMLive) (Fierce) (GSK) (RTT) (Pharma Letter)
  • Public health advocates seeing red over delay in sunscreen products (The Hill)
  • FDA Awareness Letters Have Impact, Allergan Counsel Says (Law 360)
  • FDA says working with Merck, USDA on cattle drug Zilmax (Reuters)
  • Amid cattle health concerns, Merck halts Zilmax sales (Reuters) (WSJ) (Merck) (SCRIP) (Bloomberg)
  • Lawmakers: Accelerated Approval Guide Omits FDASIA Rare Disease Mandate (IHP)
  • Court Holds That Reasonable-Not "Best"-Warnings Are Adequate (Drug and Device Law)
  • Upsher-Smith Receives Tentative NDA Approval for Vogelxo (testosterone) Gel CIII (US)
  • Abbott Labs Accused of Racketeering in Depakote Marketing Suit (Bloomberg)
  • Death Row Improvises, Lacking Lethal Mix (NYTimes)
  • FDA Seeks Specificity Over Sensitivity To ID Potentially Proarrhythmic Drugs (Pink Sheet)
  • Epizyme picks up FDA orphan nod for lead cancer drug as going public pays off (Fierce) (BioFlash)
  • Opioid Conversion Needs Outside Research Before Policy Change, FDA Says (Pink Sheet)
  • Shire Wins Dismissal Of Generic Adderall Antitrust Suit (Law 360)
  • FDA Contract: Correlation of Mesalamine Pharmacokinetics with Local Availability (FDA)
  • FDA warns of rapid, permanent nerve damage with fluoroquinolones (SCRIP)
  • Aidapak Services Llc Initiates Voluntary Recall of Selected Pharmaceuticals Repackaged by Aidapak Services Llc Due to Potential Incorrect Labeling (FDA)
  • Seven Oncologists Charged with Importing Unapproved Drugs (FDA)
  • QR codes on vaccines help collect EHR data, reduce errors (EHR Intelligence)
Pharmaceuticals: General
  • BioCentury TV: How the Genome Revolution Will Continue to Upend Pharmaceutical Development in the Next Decade (BCTV)
Medical Devices
  • FDA Calling For More PMAs Than 510(k)s In Final Set Of Preamendment Devices (Gray Sheet)
  • AdvaMed Challenges Legality Of FDA Data Transparency Efforts (IHP)
  • Pending Mobile Medical Apps Guidance Provokes Heated Controversy (Gray Sheet)
  • Bard Loses $2 Million Verdict in Vaginal-Mesh Trial (Bloomberg)
  • Understudied and underserved: Medical devices for women are a big unmet need (MedCity News)
  • Cardica files for FDA clearance for MicroCutter device (Mass Device)
  • FDA Issues Final Guidance on Radio Frequency Wireless Technology in Medical Devices (FDA Law Blog)
Assorted And Government
  • FDA Ready To Hire New Deputy Commissioner For Medical Products And Tobacco (Pink Sheet)
  • CROs may see more business with new FDA clinical trial guidelines (MedCity News)
  • FDA Cancells Contract Solicitation for "Study Data Management" Tool (FDA)
  • BIO files Amicus Brief in Federal Circuit Case of Fresenius v. Baxter (BIO)
  • US Capitol Capsule: Naive or just brazen? Docs who buy from Rx fraudsters (SCRIP)
  • BIO's Take on TTIP: Global Regulatory Cooperation and Convergence (BIO)
Upcoming Meetings And Events
  • 19 August 2013: FDA Basics Webinar: Biological Products, Part 2: Biosimilar Biological Products (FDA)
  • 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

  • How Will the EU Regulate Devices Products Intended to Enhance Human Function Instead of Correct Defecits? (Medical Devices Legal)
  • EU expands license for GSK's Tyverb (Pharma Times)
  • EFSA finds pharma pill coating is safe for food supplements (Nutra-Ingredients)
  • Irvine Scientific Receives CE approval for Continuous Single Culture and Continuous Single Culture Complete Media Used for Fertilization and Embryo Culture (Irvine)

India

  • Cipla Chairman Urges India CL For Drugs Bound For Undeveloped Markets (PharmAsia) (Economic Times)
  • India To Push Through 26 New Drugs Without Gov't Approval (Forbes) (PharmAsia)
  • Indian Parliament Debates Roles of Regulatory Bodies in Controlling Pharmaceutical Sector (PharmaBiz)
  • Now What? Roche's Move On Herceptin Shines Light On India's Biosimilars Pathway (Pink Sheet)
  • Novartis lashes out at India for not respecting IPR (India Times)

China

  • Silver Lining: Will GSK Case Increase Compliance In China? (PharmAsia)
  • China: life sciences regulatory crackdown spreads to medical device sector (Lexology)
  • China FDA Highlights Product Recalls, Urges Manufacturers To Respond Rapidly (Gray Sheet)
  • China to stop harvesting organs from executed prisoners (CBS)
  • Glaxo Trips for Chinese Doctors Played to Overburdened Medical System (WSJ)

Other International

  • Health Canada Approves ThromboGenics' JETREA for the Treatment of Symptomatic Vitreomacular Adhesion (ThromboGenics)

General Regulatory And Interesting Articles

  • First, Do No Harm: Financial Conflicts in Medicine (UCSD) (FT)
  • Who Should Biotech Pros Follow on Twitter? The 2013 Edition (Xconomy)
  • Tamoxifen cuts second cancer risk in BRCA carriers (Reuters)
  • Aspirin tied to smaller lung and colon cancer tumors (Reuters)
  • Nanosensors could aid drug manufacturing (EurekAlert)
  • Has Carl June Found a Key to Fighting Cancer? (Philadelphia Mag)

Regulatory Reconnaissance #134  - 19 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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