Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Hamburg Defends FDA's Approval of Zohydro (14 March 2014)

Regulatory Reconnaissance: Hamburg Defends FDA's Approval of Zohydro (14 March 2014)

Posted 14 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • Hamburg Defends Zohydro as Criticism Intensifies (AP) (Law 360-$) (SCRIP-$) (The Hill)
  • FDA Sued Over Failure to Issue Export Certificate (FDA Law Blog)
  • CBER Director Karen Midthun Defends FDA on Mengitis Vaccine Criticism (USA Today)
  • Facebook Slap Shows FDA Has Eagle Eye On Social Media (Law 360-$)
  • FDA to Congress: Health IT Regulatory Plan Coming Soon (Health Data Management)
  • Alliance Seeks FDA Budget of $2.784 Billion for FY 15 (StrengthenFDA)

In Focus: International

  • EU looks at new ways of reporting device-related incidents as centralization looms (Clinica-$)
  • PMCPA Issues Social Media Guidance for Pharma (Pharma Marketing Blog)
  • NICE says better information needed on Celgene's Revlimid (Pharma Letter-$) (Pharma Times)
  • Boston Scientific lands E.U. approval for Rebel bare-metal stent (Mass Device) (Fierce)
  • Indian Supreme Court Refuses to Ban Ranbaxy from Manufacturing Drugs (India Times)
  • Regulatory risk to the fore in Indian pharma stocks (LiveMint)

US: Pharmaceuticals/Biotechnology

  • Hamburg Defends Zohydro as Criticism Intensifies (AP) (Law 360-$) (SCRIP-$) (The Hill)
  • FDA Sued Over Failure to Issue Export Certificate (FDA Law Blog)
  • Facebook Slap Shows FDA Has Eagle Eye On Social Media (Law 360-$)
  • Senator: FDA "Off to a Fast Start" in Implementing New Law to Clarify Oversight of Compounding Pharmacies (Senate)
  • FDAAA 2007: Clinical Trials Disclosure - Common Mistakes in Compliance (PCM)
  • FDA's Breakthrough Products: Could Patients Drive The Designations? (Pink Sheet-$)
  • CBER Director Karen Midthun Defends FDA on Mengitis Vaccine Criticism (USA Today)
  • FDA Also Eyeing Sun Pharma's Marck Site (SCRIP-$)
  • Sen. Casey urges FDA to review naloxone (DE County Daily Times) (Casey)
  • Multiple sclerosis patients urge FDA to approve drug (USA Today)
  • GPhA meets with FDA over biosimilars naming (Biosimilar News)
  • US court decision stands in Actelion fasudil damages case (SCRIP-$)
  • Former OGD Deputy Director Sides with GPhA on Proposed Labeling Rule (Lachman)
  • Lawyers: FDA Rejection Of Labeling Won't Shield Generic Firms From Liability Under Rule (IHP-$)
  • GPhA Testimony on FDA Proposed Labeling (GPhA)
  • FDA, IP, and FTC Developments in the Run-up to the First U.S. Biosimilar Approval (JD Supra)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • FDA Accepts NDA for Veloxis' Kidney Transplant Rejection Drug Envarsus (Press) (BioCentury)
  • Phase III OA data for CrystalGenomics' polmacoxib (BioCentury)
  • Navidea Biopharmaceuticals Announces Presentation of Lymphoseek Three-Year Recurrence and Survival Outcomes after Sentinel Lymph Node Biopsy in Patients with Breast Cancer and Melanoma (Press)

US: Pharmaceuticals and Biotechnology: General

  • Pharma cargo theft takes new spike (Fierce)
  • Hikma hits the jackpot with doxycycline shortage (Fierce)

US: Medical Devices

  • FDA to Congress: Health IT Regulatory Plan Coming Soon (Health Data Management)
  • When It Comes to Medical Devices, It's Not About the Label (Medical Design)
  • Sen. Fischer Trying to Attach PROTECT Act to Legislation Moving Through Congress (Scout)
  • SafeOp Surgical lands FDA nod for neuromonitoring device (Mass Device)
  • FDA OKs Integra LifeSciences foot bone wedges (Mass Device)
  • FDA Out With New Contract Notice for State Inspections of Device Manufacturers (FDA)
  • Merit Medical gets FDA's highest-risk label over Hospira injections (Mass Device) (FDA)
  • Activists Take Fight to Obtain Hip, Knee Product Warranties to AAOS. Will They Succeed? (MDDI)

US: Dietary Supplements

  • Pom Wonderful v. Coca-Cola: Will the Supreme Court's Decision Have Implications Beyond "Pomegranate Blueberry Flavored Blend of 5 Juices"? (Harvard BOH)

US: Assorted And Government

  • Webcast of 13 March 2014 Senate Hearing on FDASIA (Senate) (Hamburg Testimony)
  • Alliance Seeks FDA Budget of $2.784 Billion for FY 15 (StrengthenFDA)
  • HHS OIG 2014 Work Plan (Policy and Medicine)
  • Veterans Affairs Issues Final Rule of Participating With Prescription Drug Monitoring Programs (VA)
  • Big Data Could Help Trial Recruitment But Would Not Replace RCTs (Pink Sheet-$)
  • Former Virginia Governor McDonnell's lawyers want federal documents from FDA (Washington Post)
  • New Anti-Regulation Bill Released in Senate (Bill)

Europe

  • EU looks at new ways of reporting device-related incidents as centralization looms (Clinica-$)
  • PMCPA Issues Social Media Guidance for Pharma (Pharma Marketing Blog)
  • NICE says better information needed on Celgene's Revlimid (Pharma Letter-$) (Pharma Times)
  • Boston Scientific lands E.U. approval for Rebel bare-metal stent (Mass Device) (Fierce)
  • Teva, UK Announce Launch of Clinical Drug Development Collaboration (Press)
  • NICE hoax emails tell thousands 'you might have cancer' (SCRIP-$)
  • MHRA highlights fault with two Abbott Diabetes Care glucose meters (PJO)
  • EFPIA calls for integrated life sciences strategy (Pharma Times)

India

  • Indian Supreme Court Refuses to Ban Ranbaxy from Manufacturing Drugs (India Times)
  • Regulatory risk to the fore in Indian pharma stocks (LiveMint)
  • India drug patent approvals up 22% in 2012-13 (SCRIP-$)

Other International

  • WHO norms for good review practices to regulatory authorities for pharma & biologicals (PharmaBiz)
  • International Consensus on "Software as Medical Device" Definition (Inside Medical Devices)
  • GHTC Briefing Paper: Addressing regulatory challenges throughout the product development process (GHTC)
  • The 'Beast' That's Driving Product Recalls (Forbes)
  • Taiwan approves TaiGen's nemonoxacin (BioCentury)

General Regulatory And Interesting Articles

  • A new book chronicles the uneasy relationship between money and drugs, and what it means for the rest of us. (CNN Money)
  • Discontinuation of randomized clinical trials common (MNT)
  • Physician: Adverse Events from Insulin Prescribing 'An Epidemic' (HealthLeadersMedia)
  • IUDs effective For longer than recommended (Reuters)
  • Statins have no side effects? What our study really found, its fixable flaws, and why trials transparency matters (again). (Bad Science)

Regulatory Reconnaissance #276 - 14 March 2014

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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