Regulatory Focus™ > News Articles > Regulatory Reconnaissance: GMP Problems Lead to Import Ban for Sun Pharma (13 March 2014)

Regulatory Reconnaissance: GMP Problems Lead to Import Ban for Sun Pharma (13 March 2014)

Posted 13 March 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

  • France Introduces New Adverse Event Reporting Requirements for Clinical Trials (ANSM)
  • Which new European medtech standards will become available in 2014? (Clinica-$)
  • NICE denies pharma influence on statin guidance (PMLive)
  • Accelerating Drug Approval Process Still A Hot Spot For National People's Congress (PharmAsia-$)
  • PhRMA positive on Japan policy changes but more needed (SCRIP-$)
  • CFDA Names New Drug Review Director (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • FDA bans imports from Sun Pharma plant in India crackdown (Reuters) (FT-$) (Bloomberg)
  • US cattle deaths linked to Merck's Zilmax far exceed company reports-study (Reuters)
  • GPhA Met With FDA to Discuss Biosimilar Naming (FDA)
  • Pfizer says U.S. court invalidates Celebrex patent; generics loom (Reuters) (Press) (WSJ-$) (SCRIP-$) (Law 360-$) (Pink Sheet-$) (PMLive) (Bloomberg)
  • E&C Hearing On FDA Generic Labeling Rule Rescheduled For April 1 (IHP-$)
  • Proposed FDA generic drug regulation: Higher prices, no public health benefit (AEI)
  • Pharmacies, AGs Claim Sides On FDA's Generic Label Plan (Law 360-$)
  • Wal-Mart Weighs in on FDA Generic Labeling Rule (GPhA)
  • FDA: Vaccines a Critical Tool in Protecting and Promoting Public Health (BIO) (FDA) (HHS)
  • OGD's Paragraph IV Database and Two Interesting Listings (Lachman)
  • Regulating compounding pharmacies through insurance (TIE)
  • Sens. Vitter, Lee, Manchin Want Investigation into Big PhRMA Allegedly Paying FDA for Drug Approval Process (Press)
  • Opioid "Pay To Play" Investigation Struggling In Congress (Pink Sheet-$)
  • Dr. Reddy's recalls some lots of heartburn drug in US (India Times)
  • Teva Agrees to Pay $27.6 Million to Settle Allegations Involving Chicago Psychiatrist (ProPublica) (DOJ) (Fierce) (SCRIP-$)
  • Pfizer Lipitor OTC Bid Would Face An FDA Evolving On Switch Innovation (Pink Sheet-$)
  • Heart Failure: The Missing 800 Pound Gorilla In Diabetes Trials (Forbes) (OnMedica)
  • Mallinckrodt's Xartemis XR Clears FDA, But Without Abuse-Deterrent Claim (BioCentury) (Pharma Letter-$) (SCRIP-$) (Press) (Pink Sheet-$)
  • Amerigen Pharmaceuticals Limited announces that its ANDA for carbidopa 25mg tablets has received final approval from FDA (Press)
  • Upsher-Smith Receives FDA Approval For Qudexy XR (Topiramate) Extended-Release Capsules (Press)
  • Geron CEO: Getting Imetelstat Data Wanted By FDA Will Be "Difficult" (Pink Sheet-$)
  • FDA Listing of Authorized Generics (FDA)

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

US: Medical Devices

  • The FDA smacks Hospira with Warning Letter over NC manufacturing problems (Fierce) (Mass Device)
  • FDA panel backs expanded label for Roche HPV test (BioCentury) (Press) (NYTimes) (Pharmafile)
  • CDRH's Owen Faris: New Clinical Trials Program Will Speed Up IDE Approvals (Gray Sheet-$)
  • Beyond CAPA: Using Risk Assessment to Streamline Your Quality System (MedDeviceSummit)
  • Surefire Medical Receives FDA Clearance, CE Mark For New Line Of Guiding Catheters (Press)
  • Greatbatch Medical's Offset Cup Impactor Recalled due to Sterilization Concerns (FDA) (FDA)

US: Dietary Supplements

  • Court Rules that FTC's Substantiation Requirements Are Applicable to Claims for Medical Foods (FDA Law Blog)

US: Assorted And Government

  • PhRMA's "I'm In" Campaign Looks To Connect Minorities To Studies (BioCentury) (Press) (SCRIP-$) (Pink Sheet-$)
  • USA's HHS establishes new network to perform clinical studies (Pharma Letter-$) (Press)
  • Reps. introduce bill to change reimbursement for antimicrobials (BioCentury)
  • FDA Enforcement Report - Week of March 12, 2014 (FDA)

Europe

  • France Introduces New Adverse Event Reporting Requirements for Clinical Trials (ANSM)
  • Which new European medtech standards will become available in 2014? (Clinica-$)
  • NICE denies pharma influence on statin guidance (PMLive)
  • Uptake challenges for personalised medicines and companion diagnostics (PMLive)

Japan & China

  • Accelerating Drug Approval Process Still A Hot Spot For National People's Congress (PharmAsia-$)
  • PhRMA positive on Japan policy changes but more needed (SCRIP-$)
  • CFDA Names New Drug Review Director (PharmAsia-$)
  • Proposals seek 'appropriate and transparent' Japan investigator studies (SCRIP-$)
  • New Rule On Long-Listed Products In Japan With Big Effect On Tanabe Mitsubishi (PharmAsia-$)

General Regulatory And Interesting Articles

  • Mix Of Gut Microbes May Play Role In Crohn's Disease (NPR)
  • Statin side-effects minimal, study finds (Guardian)

Regulatory Reconnaissance #275 - 13 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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