Regulatory Focus™ > News Articles > Regulatory Reconnaissance (17 July 2013)

Regulatory Reconnaissance (17 July 2013)

Posted 17 July 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • FDA Deals Merck Another Setback for Anesthesia Drug Sugammadex (Fierce) (Merck) (Reuters) (SCRIP) (BioCentury) (Pink Sheet)
  • BTG Unit gets FDA Warning Letter for Connecticut Plant (Fierce) (In-Pharma Technologist)
  • FDA Warns Genentech Trial Investigator Over Data Problems (Pharmalot)
  • Global Risk Management Conference Provides Insight for Upcoming FDA Public REMS Meeting (FDA Lawyers Blog)
  • US FDA Warned of Repercussions of Further Delay to Final UDI Rule (Clinica) (MedCity News)
  • Sunshine Rising Soon: Making Ready for Financial Relationship Reporting (SCRIP)
  • USPLabs Destroys $8 Million in DMAA-Containing Supplements after FDA Pressure (NYTimes)
  • How a Rule to Protect Animals Resulted in Magicians Needing Disaster Plans for Rabbits (WaPo)

In Focus: International

  • European Commission Releases 14th Revision to Packaging Guideline for Human Pharmaceuticals (EC)
  • European Commission Opens Public Consultation on GMPs (EC)
  • European Commission Opens Public Consultation on Orphan Medicinal Products (EC)
  • China Proposes Rule Requiring Registration of Clinical-Trial Participants (PharmAsia)
  • GSK Executice Admits Bribery on Live TV (Pharmafile) (Independent) (MedCity News)
  • China API Firms Knowledge of EU CEPs "Good on Paper" says Audit Firm (In-Pharma Technologist)
  • GSK Probe Shows China Corruption Endemic Since Czar Execution (Bloomberg)

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

US

Pharmaceuticals/Biotechnology
  • FDA deals Merck another setback for anesthesia drug sugammadex (Fierce) (Merck) (Reuters) (SCRIP) (BioCentury) (Pink Sheet)
  • BTG unit gets FDA warning letter for Connecticut plant (Fierce) (In-Pharma Technologist)
  • Invacare Corporation Receives FDA Acceptance of Second Certification Audit Related to Consent Decree (Invacare)
  • FDA Warns Genentech Trial Investigator Over Data Problems (Pharmalot)
  • Q1 Global Risk Management Conference Provides Insight for Upcoming FDA Public REMS Meeting (FDA Lawyers Blog)
  • FDA Continues to Solicit Comments on Drug Supply Chain Issues (FDA Law Blog)
  • FDA Approves Watson's Lamotrigine ANDA (#200828) (FDA)
  • Citizen Petition: Declare That the Drug Products, Dapsone, 50mg, is Suitable for Submission as an ANDA (FDA)
  • Citizen Petition: Declare That the Drug Products, Griseofulvin Tablets, 187.5 mg, and Griseofulvin Tablets, 375mg, are Suitable for Submission as an ANDA (FDA)
  • J&J To Pay $23M To Settle Investors' Drug Recall Suit (Law 360)
  • Mylan says court dismisses some of Teva's patent claims on MS drug (Reuters) (Law 360)
  • Otsuka/Lundbeck's Donepezil Add-On for Alzheimers Effective in PhII Trial (Otsuka) (SCRIP) (Reuters) (Fierce) (Pharmafile)
  • Baxter's Phase III Study of Immunoglobulin for Alzheimer's Disease Fails to Get Desired Results (Baxter)
  • New Analysis Shows Benefits of Pradaxa Maintained In Difficult To Treat Patients With Atrial Fibrillation And Symptomatic Heart Failure (BI)
  • Novartis's dovitinib fails pivotal trial (SCRIP)
  • XenoPort's Horizant (gabapentin enacarbil ER) no Longer Experiencing Shortages (FDA)
Medical Devices
  • US FDA warned of repercussions of further delay to final UDI rule (Clinica) (MedCity News)
  • A Clear Guidance From OIG For Device Manufacturers (Law 360)
  • Meeting Materials Posted for 18 June Dental Products Meeting (FDA)
  • Phase 1 Recall for Codman & Shurtleff's MedStream Infusion Pump (FDA) (FDA)
  • Interoperability certification program aiming to standardize patient data transmission has first graduates (MedCity News)
Assorted And Government
  • Head Of PhRMA Says Obama Budget Plans Cause Concern (KHN)
  • Sunshine rising soon: Making ready for financial relationship reporting (SCRIP)
  • USPLabs Destroys $8 Million in DMAA-Containing Supplements (NYTimes)
  • Recorded Webcast of FDA Town Hall With Patient Groups (FDA)
  • NIH confirms some clinical trials halted in India (BioCentury)
  • Cardin praises FDA for effort on health disparities (The Hill)
  • As Negotiations Begin, Advocates Decry Secrecy and Substance of U.S.-EU Trade Agreement (CFEG)
  • Free Trade Agreement Could Prioritize Commercial Interests Over Public Services (Eye for Pharma)
  • National Cancer Institute releases largest-ever cancer gene database (Reuters)
  • Clinical trial compliance software provider NextDocs raises $5M (MedCity News)
Upcoming Meetings And Events
  • 16 July 2013: Hearing: Reforming the Drug Compounding Regulatory Framework (House)
  • 18 July 2013: Meeting: Dental Products Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 18 July 2013: Meeting: Anesthetic and Analgesic Drug Products Advisory Committee (FDA)
  • 22-23 July 2013: Arthritis Advisory Committee Meeting (FDA)
  • 23 July 2013: Brookings Webinar: Active Medical Product Surveillance Roundtable (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • European Commission Releases 14th Revision to Packaging Guideline for Human Pharmaceuticals (EC)
  • European Commission Opens Public Consultation on GMPs (EC)
  • European Commission Opens Public Consultation on Orphan Medicinal Products (EC)
  • MHRA Launches "Pharmacovigilance Service Desk" to Assist Industry (MHRA)
  • UK Taxpayers Suffer As Pharma Commits 'Highway Robbery'? (Pharmalot)

Asia

  • GSK exec admits bribery on live TV (Pharmafile) (Independent) (MedCity News)
  • China API Firms Knowledge of EU CEPs "Good on Paper" says Audit Firm (In-Pharma Technologist)
  • Glaxo Probe Shows China Corruption Endemic Since Czar Execution (Bloomberg)
  • China Proposes Rule Requiring Registration Of Clinical-Trial Participants (PharmAsia)
  • Chinese commission reviewing drug pricing (BioCentury)
  • For Global Drug Manufacturers, China Becomes a Perilous Market (NYTimes)
  • China Bans Glaxo Executive From Leaving (WSJ)
  • China Approves Local Generics Of Glivec; Novartis Says Quality Doesn't Come Close (PharmAsia)
  • GSK pulls Japan Relvar filing for COPD but asthma use on track (SCRIP)
  • Ranbaxy's Toansa, Mohali plants under US FDA scanner for manufacturing practices (India Times)
  • Gujarat FDCA, Bill & Melinda Foundation to tie up for procuring drugs (PharmaBiz)
  • DTAB to review ban of three drugs in its meeting on July 19 (PharmaBiz)

General Regulatory And Interesting Articles

  • Watch him pull a USDA-mandated rabbit disaster plan out of his hat (Washington Post)

Regulatory Reconnaissance #109  - 17 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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