Regulatory Focus™ > News Articles > Regulatory Reconnaissance (26 July 2013)

Regulatory Reconnaissance (26 July 2013)

Posted 26 July 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • FDA considering breakthrough diagnostic pathway (BioCentury) (IHP)
  • FDA Places Partial hold for Vertex's HCV compound, VX-135 (BioCentury) (Vertex) (Xconomy) (Reuters) (WSJ) (The Street) (Fierce) (SCRIP) (Bloomberg)
  • BMS, AstraZeneca discloses FDA to review diabetes drug dapagliflozin again (BioCentury) (Fierce) (BMS) (PMLive) (SCRIP)
  • REMS Meeting: FDA Acknowledges Problems In Approach To Riskiest Drugs (Law 360)
  • Investigation: Sports supplement designer has history of risky products (USA Today)
  • FDA's Creation Of Pharmacologic Classes Is Mostly Reviewers' Responsibility (Pink Sheet)
  • Questions Raised About FDA's Breakthrough Resource Allocation (Pink Sheet)
  • Surgeons Eyed Over Deals With Medical-Device Makers (WSJ)
  • Former Owner of Louisville Pharmaceutical Company Pleads Guilty to FDA Violations (FDA)
  • GAO Report Slams FDA's MARCS Data Center Project for Cost, Time Overruns (GAO)

In Focus: International

  • EMA Announces Revision of a Procedural Guidance on Variations (EMA)
  • New MedDRA Website Launched (MedDRA)
  • MHRA Warns Companies to be Wary to Potential Bank Fraud Related to Regulatory Activities (MHRA)
  • European Medicines Agency recommends changes to the use of metoclopramide (EMA)
  • European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole (EMA)
  • India's New Clinical Trial Rules Slow Testing, Approval Reviews (PharmAsia)

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

US

Pharmaceuticals/Biotechnology
  • FDA Places Partial hold for Vertex's HCV compound, VX-135 (BioCentury) (Vertex) (Xconomy) (Reuters) (WSJ) (The Street) (Fierce) (SCRIP) (Bloomberg)
  • BMS, AstraZeneca discloses FDA to review diabetes drug dapagliflozin again (BioCentury) (Fierce) (BMS) (PMLive) (SCRIP)
  • REMS Meeting: FDA Acknowledges Problems In Approach To Riskiest Drugs (Law 360)
  • FDA's Creation Of Pharmacologic Classes Is Mostly Reviewers' Responsibility (Pink Sheet)
  • FDA Investigators Share Advice on Responding to Form 483 Reports (Gold Sheet)
  • Questions Raised About FDA's Breakthrough Resource Allocation (Pink Sheet)
  • FDA Proposes QbR for New Drugs to Level the Playing Field for CMC Reviews (Gold Sheet)
  • Former Owner of Louisville Pharmaceutical Company Pleads Guilty to FDA Violations (FDA)
  • Commentary: Subjecting reverse payments in patent cases to antitrust scrutiny: Sounds like a good idea, but can it work? (SCOTUSBlog)
  • US OK for Forest/Pierre Fabre antidepressant (Pharma Times) (Forest)
  • US FDA approval for Warner Chilcott's new oral contraceptive (Pharma Letter)
  • FDA Approves Dr. Reddy's ANDA for Generic Aricept (Donepezil HCl, #202723), Grants Tentative Approval to Macleods Pharma's (#202631) and full approval to Par Pharma's (#202542) Applications for the Same (FDA)
  • Vifor gets FDA approval for Injectafer (Pharma Times)
  • OGD's Supplement Team Assigning Priority to Drugs in Shortage (Gold Sheet)
  • Cancer trial results slow to see light of day: study (Reuters)
  • FDA Resolves 180-Day Exclusivity Forfeiture for Tentative Approvals that Occur on the 30-Month ANDA Submission Anniversary Date (FDA Law Blog)
  • Importing unapproved drugs: lethal injections and shortages (Harvard BOH)
  • Takeda's orteronel misses PhIII endpoint in post-chemo prostate cancer (SCRIP) (Takeda)
  • Mylan Confirms First-to-File Patent Challenge by Eisai Relating to Banzel (Mylan)
  • NIH Begins Gene Therapy Trial for Parkinson's Disease (Scientific American)
  • INDICTED: Criminal charges filed against hedge fund in bapineuzumab case (SCRIP)
Medical Devices
  • FDA considering breakthrough diagnostic pathway (BioCentury) (IHP)
  • Abbott wins FDA nod for glucose monitor (Fierce) (Abbott)
  • FDA permits marketing of first U.S. test labeled for simultaneous detection of tuberculosis bacteria and resistance to the antibiotic rifampin (FDA)
  • Surgeons Eyed Over Deals With Medical-Device Makers (WSJ)
  • Johnson & Johnson subsidiary gets Class I recall for implantable infusion pumps (Mass Device)
  • Recall: FDA slaps Ohio-based Bryan Medical with its highest-risk recall (Mass Device)
  • Cepheid Receives FDA Market Authorization for Xpert MTB/RIF (PR Newswire)
  • Pact aligns LOINC and SNOMED terminologies (Fierce) (Modern Healthcare)
Assorted And Government
  • Investigation: Sports supplement designer has history of risky products (USA Today)
  • GAO Report Slams FDA's MARCS Data Center Project for Cost, Time Overruns (GAO)
  • The 'Secret' Milgram Experiments (Chronicle of Higher Ed)
  • Senate regulatory panel to hold inaugural hearing (The Hill)
  • Bill would require more lists of expected rules (The Hill)
  • National Toxicology Program Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for Comments (NIH)
  • Health Law Boosts Status Of Alternative Medicine -- At Least On Paper (KHN)
Upcoming Meetings And Events
  • 22-23 July 2013: Arthritis Advisory Committee Meeting (FDA)
  • 23 July 2013: Meeting: Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study (FDA)
  • 23 July 2013: Hearing: "Pay-for-Delay Deals: Limiting Competition and Costing Consumers" (Senate Judiciary Cmmte)
  • 23 July 2013: Brookings Webinar: Active Medical Product Surveillance Roundtable (FDA)
  • 24 July 2013: Answering a Compelling Need: Expediting Life-Saving Treatments to Patients (FOCR)
  • 24 July 2013: House Hearing on US-EU Free Trade Agreements and Regulatory Barriers (House)
  • 25 July 2013: CBER Webinar on its Direct Recall Classification Program (FDA)
  • 25 July 2013: Webinar on FDA's Draft GFI on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment (FDA)
  • 25 July 2013: Webinar on FDA's Draft GFI On Rheumatoid Arthritis - Developing Drug Products For Treatment (FDA)
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA Announces Revision of a Procedural Guidance on Variations (EMA)
  • MHRA Warns Companies to be Wary to Potential Bank Fraud Related to Regulatory Activities (MHRA)
  • European Medicines Agency recommends changes to the use of metoclopramide (EMA)
  • European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole (EMA)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013 (EMA)
  •  UK's MHRA Enhances Risk-Based Inspection Process (Gold Sheet)
  • Richard Bergström Explains Transatlantic Joint Principles for Clinical Data Sharing (Eye for Pharma)
  • CHMP again rebuffs Pfizer's Xeljanz (Fierce) (Pharma Times)
  • J&J not so lucky to escape Authority wrath over mouthwash ad (Cosmetics Design)

Asia

  • Glaxo Replaces Chief of China Unit at Center of Bribery Inquiry (NYTimes) (Fierce) (AP) (Reuters) (WSJ)
  • China Details Allegations Against Glaxo (NYTimes)
  • India's New Clinical Trial Rules Slow Testing, Approval Reviews (PharmAsia)

Other International

General Regulatory And Interesting Articles

  • Deadly Middle East virus unlikely to cause SARS-like epidemic (Reuters)

Regulatory Reconnaissance #117  - 26 July 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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