Regulatory Focus™ > News Articles > Regulatory Reconnaissance (7 May 2013)

Regulatory Reconnaissance (7 May 2013)

Posted 07 May 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

In Focus: International

  • Panel finds wrong information, names of banned drugs in official website of CDSCO (PharmaBiz)
  • Industry: Trans-Tasman Warning System Could Spark Unnecessary Concerns (FDA News) ($)
  • Unethical clinical practices by foreign pharma cos causing more deaths in India (PharmaBiz)
  • India tightens up clinical-trial monitoring (Pharma Times)
  • UK drug pricing plan could trigger 'avalanche of problems' (Financial Times)

Comments? Suggestions? Shoot me an email at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • Abbvie Gets Breakthrough Status for HCV Therapy ABT-450 (AbbVie) (Pharma Times) (PMLive) (SCRIP Intelligence) (BioSpectrum) (Boston Biz Journal) (BioSpace) (Medical Daily) (The Pharma Letter) (Fierce Biotech)
  • Novartis promises to test the full value of FDA's 'breakthrough' status (Fierce Biotech)
  • Form 483, Response Released for Alexion Pharmaceuticals Inspection (FDA)
  • States take lead on compounding pharmacies (Politico)
  • On the Trail of Drug Risks: Many problems with therapies show up post-FDA approval. Could mining electronic data and online chatter head off trouble? (ProtoMag)
  • Safety group forewarned about Genentech drug name confusion (SCRIP Intelligence) ($)
  • Hospira says Troubled Plant on 'Rocky' Road to Recovery (Outsourcing Pharma)
  • Johnson & Johnson, Pfizer target painkiller revivals as FDA warms to abuse deterrents (Fierce Biotech)
  • NY judge urged not to delay morning-after decision (AP)
  • California Responds To The Senate Pharma Track & Trace Discussion Draft (RxTrace)
  • FDA Approves ANDAs for Sandoz's Candesartan Cilexetil (#078702), Strides Arcolab's Hydralazine HCl (#200770), and tentative approval for Mylan Pharmaceuticals' Varenicline (#202019) (FDA)
  • FDA delays PDUFA date for GSK's trametinib (BioCentury)
  • Proposed sourcing on Supreme Court reverse payment drug patent case; lawyers' views (The Pharma Letter)
  • Union Suit Claims Warner Chilcott Schemed to Stall Generics (FDA News) ($)
  • Bristol-Myers, AstraZeneca report positive data for rare metabolic disease drug (Fierce Biotech)
  • Celgene nabs another round of promising pivotal apremalist data for psoriatic arthritis (Fierce Biotech)
  • Opinion: Fire Aveo's CEO for Incompetence and Arrogance Rivaling ImClone's Sam Waksal (The Street)
  • Baxter Immunoglobulin Fails to Aid Alzheimer's Patients in PhIII Study (Bloomberg) (Baxter)
  • Low-estrogen oral contraceptives linked to pain during sex (UPI)
  • Lilly Announces CEO Dr. John Lechleiter to Undergo Scheduled Surgery (Eli Lilly)
  • Florida legislature passes biosimilar substitution bill (DSN) (GPhA)
Medical Devices
  • Medtronic wins FDA nods for next-gen cardiac devices (Fierce Medical Devices) (Mass Device) (MedGadget) (Bloomberg)
  • More Specific Device Cost Data May Inform Medicare Inpatient Payments In FY 2014 (The Pink Sheet) ($)
  • SpinalMotion wins FDA panel review date for metal-on-metal artificial disc (Mass Device)
  • Docs defend Medtronic in brain implant recall, analysts say it's no "big deal" (Mass Device)
  • Medical Devices Fall Short for Children (NYTimes)
  • Pediatric Niche Needs Can Not Be Met by the For-Profit Industry, Says Nonprofit Founder (Medtech Insider)
  • Boston Scientific Completes First-In-Human Clinical Trial of the IntellaTip MiFi™ XP Ablation Catheter For Patients With Type 1 Atrial Flutter (Boston Scientific)
  • If Tanning Beds Were a Drug, They'd Be Illegal (Forbes)
Assorted
  • AHPA, Other Supplement Groups Seek FDA Guidance on NDIs (Natural Products Insider) (Nutraingredients USA) (DSN)
  • FDA to consider revamping food additive rules (Reuters)
  • FDA Issues May 2013 Update to Regulatory Procedures Manual (FDA)
  • Honoring an FDA Champion of Safe Treatments for Children: Dr. Dianne Murphy (FDA)
  • Study on Influenza Virus (H5N1/H1N1) Infected Ferrets (FDA)
  • New FDA Staff Manual for the Office of Coordinated Outbreak Response and Evaluation Network (FDA)
  • Physician Payment Sunshine Act: CMS-OMB Posts New Request for Comments (Policy and Medicine)
  • Physician Payment Sunshine Act: CMS National Physician Payment Transparency Program (Open Payments) Town Hall Meeting: What Health Care Providers Need To Know (Policy and Medicine)
  • Physician Payment Sunshine Act: CMS Releases List of Teaching Hospitals for 2013 Reporting Period (Policy and Medicine)
  • Physician Payment Sunshine Act: CMS Posts Reporting Templates for 2013 (Policy and Medicine)
  • CSPI Accuses Bayer Multivitamins of Deceptive Breast Cancer Claims (Natural Products Insider)
  • Monster Beverage Under Fire for Marketing to Children Despite Alleged Health Risks (WSJ)
  • FTC Votes Unanimously to Retain July 1 Date for Implementation of the Updated Children's Online Privacy Protection Rule (FTC)
Government and Budget
  • Administration seeks input on Japanese trade talks (The Hill)
  • IPR concerns keep China, India on USTR priority watch (SCRIP Intelligence) ($)
Upcoming Meetings and Events
  • 7 May 2013: Energy and Commerce Committee Hearing on Track and Trace (E&C)
  • 8-9 May 213: Summit on Color in Medical Imaging (FDA)
  • 8 May 2013: Vaccines and Related Biological Products Advisory Committee (FDA)
  • 8 May 2013: Intelligence Squared Debate: Is FDA's Caution Harzardous to our Health? (IQ2)
  • 9 May 2013: Senate HELP Committee Hearing on Pharmaceutical Compounding and its Proposed Legislative Solution (Senate)
  • 9 May 2013: FDA Listening Tour on Antibiotic Resistance (FDA)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • 17 May 2013: NCATS Meeting (NCATS)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • Panel finds wrong information, names of banned drugs in official website of CDSCO (PharmaBiz)
  • Industry: Trans-Tasman Warning System Could Spark Unnecessary Concerns (FDA News) ($)
  • Unethical clinical practices by foreign pharma cos causing more deaths in India (PharmaBiz)
  • India tightens up clinical-trial monitoring (Pharma Times)
  • UK drug pricing plan could trigger 'avalanche of problems' (Financial Times)
  • EUnetHTA JA2 3-year Work Plan is available (EUnetHTA)
  • New ISO Standard on Condoms (ISO)
  • Scottish drugs watchdog told: "hold your meetings in public" (Pharma Times)
  • GSK gets £5m grant from Wellcome Trust to Develop Untreated Diseases (Pharma Times)
  • Halaven filed in EU for earlier-line breast cancer (SCRIP Intelligence) (Eisai)
  • Japan Approves 7 Drugs Including Hypertension Tape (PharmAsia News)
  • Karnataka drug control dept all set to establish biological drug lab, mobile drug test vans (PharmaBiz)
  • Expert Indian panel on FDCs to submit final draft of guidance document to health ministry by end of May (PharmaBiz)

General Regulatory and Interesting Articles

  • Medical Equipment Donated to Developing Nations Usually Ends Up on the Junk Heap (Scientific American)
  • Even Pharma's Good Deeds Are Criticized (Forbes)
  • A Cell Phone in a Pill Bottle, to Text You to Remember Your Meds (Scientific American)
  • A Forgotten Pioneer of Vaccines: Maurice Hilleman (NYTimes)

Regulatory Reconnaissance #61 - 7 May 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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