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

Regulatory Reconnaissance (10 May 2013)

Posted 10 May 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • FDA Begins Gearing up to Hire Huge Number of New Employees to Meet GDUFA Targets (FDA)
  • J&J Balks on Deal to Settle Risperdal Probe (WSJ)
  • Novartis gets FDA green light for new Ilaris indication (PMLive) (Pharma Times) (Reuters) (The Pharma Letter)
  • Stakeholders comment on FDA's benefit-risk framework (BioCentury)
  • Apple's iPad 2 may interfere with heart devices (CBS) (Bloomberg)
  • Is FDA Regulation Hazardous to Our Health? (Medical Progress Today)
  • FDA's Appropriated Budget is Less Than the School Board of the County in Which its HQ is Located (YouTube)

In Focus: International

  • Bribery Leads to Shakeup at Russian Medical Device Regulator (Emergo)
  • U.K. pair challenges earlier finding that substanded PIP breast implants were safe (Fierce Medical Devices)
  • Bangladesh Drug Firms Urge Fellow LDCs To Form One Approval Network (PharmAsia News)

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

US

Pharmaceuticals/Biotechnology
  • FDA Begins Gearing up to Hire Huge Number of New Employees to Meet GDUFA Targets (FDA)
  • J&J Balks on Deal to Settle Risperdal Probe (WSJ)
  • Novartis gets FDA green light for new Ilaris indication (PMLive) (Pharma Times) (Reuters) (The Pharma Letter)
  • Stakeholders comment on FDA's benefit-risk framework (BioCentury)
  • GPhA Blasts Attempts to Limit Biosimilar Prescribing (NYTimes)
  • Warner Chilcott, PLC Scores FDA Approval for Its New Oral Contraceptive (NDA #203667) (BioSpace) (Pharma Times) (FDA)
  • FDA Approves ANDA for Versapharm's Triamcinolone Acetonide (#203388) and tentatively approves TWI Pharms' Guanfacine Hydrochloride (#201408) (FDA)
  • Sarepta up as CEO says he's 'encouraged' on accelerated approval (Boston Biz Journal) (SCRIP Intelligence)
  • Salix appealing Relistor complete response letter (BioCentury)
  • FDA to discuss Merck's sugammadex (BioCentury)
  • Negative Impact of Anesthesia Drug Shortages Lessened through Improved Communication Efforts, Survey Data Reveal (AANA)
  • Potential Xyrem REMS Changes Could Invite Generics (FDA News) ($)
  • Meetings: Anesthetic and Analgesic Drug Products Advisory Committee (FDA)
  • FDA Seeks Comment on Proposed Information Collection Regarding Newly-Authorized Generic Medicines (FDA)
  • Senator Calls out Labor Secretary Nominee for Supporting Drug Reimportation (Congress)
  • Shire Blocks Actavis' Generic Lialda Until 2020 (Law 360) ($)
  • LCD Cases May Give Drug Cos. Gold Ticket Out Of State Court (Law 360) ($)
  • Big Drug Companies Are Selling Fewer Pills, But Charging More (Forbes)
  • DEA collects more than 740,000 pounds of unused drugs (DSN)
  • CytRx Corporation Ditches Lung Cancer Drug After Phase 2 Trial Failure (BioSpace)
  • Bimeda Inc. on Behalf of Manufacturer Bimeda-MTC Animal Health Inc. Issues Voluntary Nationwide Recall of Sterile Solutions Due to Concerns Regarding Sterility and Possible Health Risk (FDA)
Medical Devices
  • Apple's iPad 2 may interfere with heart devices (CBS) (Bloomberg)
  • FDA Receives Over 45,000 Reports of Mirena IUD Injuries, Says Law Firm (PRWeb)
  • US-Based mHealth Regulatory Coalition says its Working on a Strategic Plan to Address Changes in the EU (MRC)
  • Boston Scientific Touts Data on Watchman Device, Claims Superior to Warfarin for A-Fib (Boston Scientific) (Mass Device)
  • NEC Display Solutions Receives FDA 510(k) Clearance on MD211C2 and MD211C3 Medical Diagnostic Monitors (Business Wire)
  • Class 1 Recall: Abbott's FreeStyle InsuLinx Blood Glucose Monitoring System (FDA)
  • Masimo RAS-125c Acoustic Respiration Cloth Sensor Now FDA Cleared for Pediatric Use ( (MedGadget)
  • Combat Ready Clamp Cleared for Stopping Acute Bleeding (MedGadget)
  • Glooko's New Diabetes Management System FDA Cleared (MedGadget)
  • Former Senior Executive of Arthrocare Corp. Pleads Guilty in $400 Million Securities Fraud Scheme (DOJ)
  • HRS 2013: St. Jude Medical touts independent safety data for next-gen Durata leads (Mass Device) (St Jude)
  • Houston medical device company Arcos gets FDA clearance (Houston Biz Journal)
  • FDA Gets OMB Approval for Collection of Information on " Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable" (FDA)
Assorted
Government and Budget
  • Experts call for outside panel to weed out useless regulations (The Hill)
  • House Oversight chair rips White House on blown deadline (The Hill)
Upcoming Meetings and Events
  • 7-8 May 2013: House Hearing on Track and Trace (House)
  • 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

  • Bribery Leads to Shakeup at Russian Medical Device Regulator (Emergo)
  • U.K. pair challenges earlier finding that substanded PIP breast implants were safe (Fierce Medical Devices)
  • Bangladesh Drug Firms Urge Fellow LDCs To Form One Approval Network (PharmAsia News)
  • Ranbaxy sees tough quarter as it recovers from manufacturing mess (Fierce Pharma Manufacturing)
  • Intas launches biosimilar rituximab in India (BioCentury)
  • Medtech's mini guide to…centralized and decentralized regulatory procedures (Clinica)
  • Brazil demands an inside-out strategy (Clinica)

General Regulatory and Interesting Articles

  • On the web, clinical trial participants find information and comfort (Med City News)
  • GSK and Save the Children form unique partnership to save the lives of one million children (GSK) (GSK) (Merck)
  • Studies show cheaper drugs don't add up to greater use (MM&M)
  • Does Consent Bias Research? (SSRN)
  • Analysis Shows Cancer Biorepository Speeds Clinical Trials, Drug Development (MNT)

Regulatory Reconnaissance #64 - 10 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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