Regulatory Focus™ > News Articles > Regulatory Reconnaissance (30 July 2013)

Regulatory Reconnaissance (30 July 2013)

Posted 30 July 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • First-time PMAs Granted in 2013 Declines Precipitously (MDDI) (Report)
  • Sanofi allergy drug safe enough for non-prescription use: FDA reviewers (Reuters) (WSJ) (MedPage Today)
  • FDA notes 'technical deficiencies' in Chelsea's drug filing (Fierce) (Pharma Letter) (Pink Sheet) (SCRIP)
  • Antibiotic Guide Lays Groundwork For Limited Population Approval Pathway (IHP)
  • FDA Releases Updated SPL Terminology Validation Files, Unique Ingredient Identifiers (FDA)
  • OPDP: There Are "A Number of Things" Companies Can Do to Avoid Enforcement Actions (CHC)
  • Mallinckrodt New Drug Application Granted Priority Review by FDA (Mallinckrodt) (Pharma Letter) (BioCentury) (SCRIP) (Pharma Times)

In Focus: International

  • 2012 annual report on EudraVigilance published (EMA)
  • EDQM "Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs" and related documents revised (EDQM)
  • European Medicines Agency provides advice on use of colistin and tigecycline in animals to reduce antimicrobial resistance (EMA)
  • Indian Patent Office Refuses Roche's Divisional Applications On Herceptin (PharmAsia)
  • Russian government to regulate prices for essential drugs (Pharma Letter)
  • Novartis Japan Says Probe Finds No Trial Impact By Employee Dual Role (Pink Sheet)
  • Proposal to restructure Kenya drug regulator (PharmAfrica)

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

US

Pharmaceuticals/Biotechnology
  • Sanofi allergy drug safe enough for non-prescription use: FDA reviewers (Reuters) (WSJ) (MedPage Today)
  • FDA notes 'technical deficiencies' in Chelsea's drug filing (Fierce) (Pharma Letter) (Pink Sheet) (SCRIP)
  • Antibiotic Guide Lays Groundwork For Limited Population Approval Pathway (IHP)
  • FDA Releases Updated SPL Terminology Validation Files, Unique Ingredient Identifiers (FDA)
  • FDA CONCURS: No confirmation of new GLP-1, DPP-4 pancreatic concerns (SCRIP)
  • OPDP: There Are "A Number of Things" Companies Can Do to Avoid Enforcement Actions (CHC)
  • Anacor Pharmaceuticals Announces That It Has Submitted a New Drug Application to the FDA for Tavaborole (Anacor) (SCRIP)
  • Mallinckrodt New Drug Application Granted Priority Review by FDA (Mallinckrodt) (Pharma Letter) (BioCentury) (SCRIP) (Pharma Times)
  • FDA Approves ANDAs for Taro's Levocetirizine (#202673), Apotex's Fenofibrate (#202252), Actavis' Doxepin HCl (#201951), Par Pharmaceuticals' Cyclobenzaprine HCl (#090864) and Lupin's Armodafinil (Tentative, #200751) (FDA)
  • Biologics Group: Biosimilars Must have Unique Naming Convention (ASBM)
  • New Details on Proposed FDA Study on Budeprion (FDA)
  • Patient taking Novartis MS pill developed rare disease (Reuters)
  • How Verastem hopes to get from founding to NDA in 6 years (BioFlash)
  • Rebiotix Receives FDA IND Approval to Begin Phase 2 Trial of Pioneering Microbiota Restoration Therapy (Rebiotix)
  • Opinion: Pharma Fails Credibility Test, Misses Opportunity, on Transparency (Xconomy)
  • New Data Could Open Vertex's CF Drug to 400 More Patients (Xconomy) (SCRIP) (The Street)
  • Pharmacists Group Lobbies Against Senate Compounding Bill (Pharmalot)
  • FDA's MedWatch Safety Alerts: June 2013 (FDA)
  • Dr. Reddy's launches generic Alzheimer's disease drug (DSN)
  • High Times For 'Low T': Inside A Testosterone-Fueled Phenomenon (Kera News)
Pharmaceuticals: General
  • Pfizer to split operations three ways (Fierce)
  • California Stem Cell Agency to Allocate $70M for Clinical Trials (Outsourcing Pharma)
  • DHHS Touts $7 Billion Saved by Seniors as Result of Obamacare (DHHS)
  • NABP Warns: Fake Online Pharmacy Collective Pretends To Be Canadian Pharmacies (Safe Medicines)
  • PIPC: PCORI Excluding Patients From CER-Communication Roundtable (IHP)
Medical Devices
  • First-time PMAs Granted in 2013 Declines Precipitously (MDDI) (Report)
  • The FDA's 510(k) Approval Process in Medical-Device Litigation (ABA)
  • GE recalls scanners after patient crushed to death (Fierce)
  • The Case for Leaving the 510(k) Argument Out of a Pleading (ABA)
  • Nova Max Glucose Test Strips: Recall - May Report False, Abnormally High Blood Glucose Result (FDA)
  • NeuroSigma wins an FDA green light for Phase III clinical trials (Mass Device) (NeuroSigma)
  • Patent Attorneys Vent Frustrations Over Supreme Court Diagnostics Rulings (Pink Sheet)
  • The Noneffect Of Myriad On Personalized Medicine (Law 360)
  • IntelligentMDx Receives FDA Clearance for IMDx VanR for Abbott m2000 assay (IntelligentMDx)
  • Trio awarded DARPA contract to create a portable device that treats sepsis (MedCity News)
Assorted And Government
  • FDA Official: Agency Plans To Beef Up Enforcement On Supplement Claims (IHP)
  • Research chimps' futures are uncertain after program is cut (Journal Sentinel)
  • Panel Urges Lung Cancer Screening For Millions Of Americans (NPR)
  • Might You Be An "Importer" for Purposes of FSMA's FSVP Requirement? Now You Know. (FDA Law Blog)
  • GOP launches summer assault on regulations (The Hill)
  • H.R.2835 -- Restoring Access to Medication Act of 2013 (House)
  • H.R.2843 -- Medicare Data Access for Transparency and Accountability Act (House)
  • H.R.2845 -- Diabetic Testing Supply Access Act of 2013 (House)
Upcoming Meetings And Events
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 29 July 2013: Workshop on Clinical Development Programs for Opioid Conversion (FDA)
  • 30-31 July 2013: Workshop on Battery-Powered Medical Devices (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • 2 August 2013: Blood Products Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • 2012 annual report on EudraVigilance published (EMA)
  • EDQM "Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs" and related documents revised (EDQM)
  • European Medicines Agency provides advice on use of colistin and tigecycline in animals to reduce antimicrobial resistance (EMA)
  • FMD Implementation Drives Better API Sourcing Knowledge and Interagency Communications (IPQ)
  • Fight for Transparency Heats Up: Industry turns to courts to stop policy in EU, offers own approach (Burill Report)
  • HAI Europe questions pharma commitment to clinical trial data transparency, claiming leaked documents suggest otherwise (Pharma Letter)
  • UK: NICE's Looming Value-Based Pricing Challenges (PharmExec)
  • Teva MS Drug Patent Backed By UK High Court In Mylan Row (Law 360) (Teva)

Asia

  • Indian Patent Office Refuses Roche's Divisional Applications On Herceptin (PharmAsia)
  • Russian government to regulate prices for essential drugs (Pharma Letter)
  • Novartis Japan Says Probe Finds No Trial Impact By Employee Dual Role (Pink Sheet)
  • Japan Opens Probe Into Skin-Sore Side Effects With Novartis Drug (PharmAsia)
  • Novartis Chief Sees Cheaper Drugs Coming With ASEAN Common Market (PharmAsia)
  • China Drug Industry Expert Says 20% Of Average Drug Cost Is Bribery (PharmAsia)

Other International

  • Boston Scientific Issues Recall for Promus Element Plus Monorail everolimus-eluting coronary stent system in Australia (TGA)
  • Proposal to restructure Kenya drug regulator (PharmAfrica)
  • Africa 'the next frontier for life sciences logistics' - DHL (PharmAfrica)

General Regulatory And Interesting Articles

  • Orphan Drug Adoption: the More Regulation, the Better (PharmExec)
  • CROs Press for More Adaptive Trials and Predict Surge in Demand (Outsourcing Pharma)
  • Definition of Cancer Should Be Tightened, Scientists Say (NYTimes) (NBC)

Regulatory Reconnaissance #120  - 30 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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe