Regulatory Reconnaissance: The Jaw-Dropping Violations That Got Sun Pharma Banned (25 April 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: [email protected].

Focus is putting together an advisory committee of Regulatory Intelligence professionals to help us inform and guide our coverage of regulatory events. Interested? Send us an email at [email protected] with the subject line Regulatory Intelligence.

In Focus: US

• Report: Industry's regulatory-centric focus for manufacturing will no longer cut it (Fierce)
• FDA AdComm Meeting to Probe Risks of Chantix and Serious Neuropsychiatric Side Effects (FDA)
• FDA Approves Roche's HPV Test for First-Line Primary Screening for Cervical Cancer (Roche) (FDA) (NYTimes) (WaPo) (FDA) (Reuters) (NBC) (WSJ-$) (Gray Sheet-$) (Modern Healthcare)
• FDA Panel Says No to Shock Therapy Device (MedPage Today) (Examiner) (CBS)
• FDA Hopes To Formalize Agency, Payor Meetings To Speed Device Coverage (IHP-$)
• Hamburg Reflects on Five Years at FDA (FDA)

In Focus: International

• The Story Behind Sun Pharma's Banned Drug Facility and its Jaw-Dropping Problems (Live Mint) (Bloomberg)
• EMA Releases Revised Pharmacovigilance Practice Guidelines (Module XVI) (Annex I) (Module V)
• UK Medical Innovation Bill: warning to pharma (Pharma Times)
• Regulatory issues crush India's drug export growth (Fierce)
• Indian Health Ministry Plans Probe of Drug Quality (PharmaBiz)

US: Pharmaceuticals/Biotechnology

• Report: Industry's regulatory-centric focus for manufacturing will no longer cut it (Fierce)
• FDA AdComm Meeting to Probe Risks of Chantix and Serious Neuropsychiatric Side Effects (FDA)
• Hamburg Defends FDA's Record on Opioid Abuse (FDA)
• DQSA: Why Randomization is Needed (RxTrace)
• Arkansas Court Won't Reconsider Risperdal Case (AP) (Law 360-$)
• Ranbaxy may launch generic of Novartis' Diovan in US soon (India Times)
• Pfizer, Actavis settle Celebrex patent litigation (SCRIP-$)
• Jubilant Life Sciences gets USFDA nod for generic drugs (India Times)
• Takeda May Not Cover Lilly's Share of Diabetes-Drug Lawsuit (WSJ-$)

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

• Alexion Submits Rolling BLA for asfotase alfa to treat hypophosphatasia (BioCentury)
• Novartis lung drug not inferior to GSK's Seretide, study shows (Reuters)
• Merck releases positive Ph IIIb results for Kuvan (Pharma Letter-$)

US: Pharmaceuticals and Biotechnology: General

• HHS leaders call for expanded use of medications to combat opioid overdose epidemic (NIH)
• New Hepatitis Drugs Vex Prisons (WSJ-$)
• NY Bill Would Require an Opiod Antagonist Like Naloxone to Accompany Every Prescription of Opioid Analgesics (One Per Year) (NY)
• Drug costs and prices: Here we go again (Scientific American)
• Vaccines prevent more than 700,000 child deaths in the U.S.: CDC (Reuters)

US: Medical Devices

• FDA Approves Roche's HPV Test for First-Line Primary Screening for Cervical Cancer (Roche) (FDA) (NYTimes) (WaPo) (FDA) (Reuters) (NBC) (WSJ-$) (Gray Sheet-$) (Modern Healthcare)
• FDA Panel Says No to Shock Therapy Device (MedPage Today) (Examiner) (CBS)
• FDA Hopes To Formalize Agency, Payor Meetings To Speed Device Coverage (IHP-$)
• Medtronic Get Extra FDA Attention To Hasten Approval Of Next-Gen Insulin Pump (Gray Sheet-$)
• The Threatened Future of US Medical Innovation (Policy and Medicine)
• Shimadzu Sonialvision G4 universal R/F system receives FDA clearance (Press)
  FBI warns healthcare of vulnerability to cyberattacks (Fierce)

US: Assorted And Government

• Hamburg Reflects on Five Years at FDA (FDA)
• AHRQ Stops Practice of "Academic Detailing" (DrugWonks)
• How Can We Increase Minority Participation in Clinical Trials? (Lilly)

Europe

• EMA Releases Revised Pharmacovigilance Practice Guidelines (Module XVI) (Annex I) (Module V)
• Boehringer criticises German drug price freeze (PMLive)
• UK Medical Innovation Bill: warning to pharma (Pharma Times)

India

• The Story Behind Sun Pharma's Banned Drug Facility and its Jaw-Dropping Problems (Live Mint) (Bloomberg)
• Regulatory issues crush India's drug export growth (Fierce)
• Indian court sets 3-parameter format for trial applicants (SCRIP-$)
• Strides Arcolab gets USFDA approval for Bangalore facility (India Times)
• Indian Health Ministry Plans Probe of Drug Quality (PharmaBiz)

General Regulatory And Interesting Articles

• Bugs 'R Us: The War Against Microbes (CBC)

Regulatory Reconnaissance #305 - 25 April 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 [email protected].

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.