Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Increasing Presence in India With More Staff (18 February 2014)

Regulatory Reconnaissance: FDA Increasing Presence in India With More Staff (18 February 2014)

Posted 18 February 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • FDA Strengthens Regulatory Presence in India With Additional Staff (WSJ-$)
  • As US biosimilar activity rises, is the first filing imminent? (SCRIP-$)
  • Hamburg set to wrap up India trip on tough note (Business-Standard)
  • Drug Quality Concerns Spur New U.S. FDA Oversight Effort (Bloomberg)
  • FDA: We're Committed to Determining Sex Differences in How Drugs Work (FDA)
  • ANDA Application Backlogs, Submission Bubbles Plague User Fee Rollout (Pink Sheet-$)
  • FDA Outlines Feedback Process For Medical Device Approvals (Law 360-$) (FDA)
  • Opponents say PROTECT Act could destroy mHealth, endanger patients (mHealthNews)

In Focus: International

  • Medicines Made in India Set Off Safety Worries (NYTimes)
  • Gujarat Regulators Warn Companies About Criminals Impersonating the US FDA (PharmaBiz)
  • Indian policy on clinical research restrictive: US pharma companies (India Times)
  • DCGI to allow import of drug with residual shelf life less than 60% under special conditions (PharmaBiz)
  • Roll up, roll up! See the incredible shrinking NICE reform! (SCRIP-$)
  • PhRMA Wants EU Put On US's 'Priority Watch List' For Plans To Disclose Basic Safety Info About Drugs (Tech Dirt)
  • France's MNSA Grants Temporary Approval to J&J/Pharmacylics' CLL Drug Ibrutinib (MNSA)

US: Pharmaceuticals/Biotechnology

  • FDA Strengthens Regulatory Presence in India With Additional Staff (WSJ-$)
  • As US biosimilar activity rises, is the first filing imminent? (SCRIP-$)
  • Hamburg set to wrap up India trip on tough note (Business-Standard)
  • Drug Quality Concerns Spur New U.S. FDA Oversight Effort (Bloomberg)
  • Opinion: If A Drug Is Good Enough For Europeans, It's Good Enough For Us (Health Affairs)
  • Bob Pollack on Improving FDA's ANDA Review Process (Lachman Consultants)
  • Hamburg: Quality: A Recurring Theme During My Visit to India (FDA)
  • FDA Is Committed to Determining Sex Differences in How Drugs Work (FDA)
  • Sickle Cell Patients Weigh Clinical Trial Participation At FDA Meeting (Pink Sheet-$)
  • ANDA Application Backlogs, Submission Bubbles Plague User Fee Rollout (Pink Sheet-$)
  • FDA Electronic Submission Deadlines Becoming Pixilated (Pink Sheet-$)
  • FDA Northera decision due on Tuesday (BioCentury)
  • FDA approves BioMarin's Vimizim (BioCentury) (SCRIP-$) (MedPage Today) (PMLive)
  • Biosimilar Substitution Could Rely On Electronic Medical Records (Pink Sheet-$)
  • NSAID Panel Highlights Challenge Of Getting Comparative Safety Claim (Pink Sheet-$)
  • Outsourcing Production Is First Step In Staving Off GMP Consent Decrees (Tan Sheet-$)
  • BioCentury TV on the Biosimilars Naming Issue (BioCenturyTV)
  • Building a Case, FDA AdComm Prep - Part 3 (Eye on FDA)
  • FDA reschedules cell therapy workshop (BioCentury)
  • GDUFA Transparency and Inspection Metrics (Pink Sheet-$)
  • Drug Shortage Scrutiny: GAO Plans Study Of FDA's Expedited Applications (Pink Sheet-$)
  • Lance vs. Wyeth - PA Supreme Court: Pharmaceutical Companies Can Be Sued for Lack of "Due Care" by Introducing Dangerous Drugs to the Market (Policy and Medicine)
  • FDA Posts Meeting Materials for Anesthesiology and Respiratory Therapy Devices Panel (FDA)
  • Ben Venue Laboratories, Inc. Issues A Voluntary Nationwide Patient Level Recall Of Acetylcysteine Solution 10%, Usp, Lot 2005479 (FDA) (FDA) (Fierce)
  • Medisca Recalls L-Citrulline Lots Amid FDA Warning (Law 360-$) (NBC) (Reuters)
  • Mylan recalls injectable drugs after pieces of label found in some vials (Fierce) (PharmPro)
  • New FDA Policies on Antibiotics Use in Food Animal Production (Pew)

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

  • Bayer's Long-Acting Recombinant Factor VIII Demonstrated Effective Prophylaxis with Less Frequent Infusions in Hemophilia A in Phase III Trial (Press)
  • Study shows potential of Pfizer's Lyrica in RLS (Pharma Times)
  • Navidea Announces Priority Review for the sNDA to Expand Lymphoseek Labeling for Sentinel Lymph Node Detection in Patients with Head and Neck Cancer (Press)

US: Pharmaceuticals and Biotechnology: General

  • It's Proven To Save Lives, So Why Is Maine Opposed To Narcan? (NPR)
  • US cancer care researchers say "cut drug prices" (Pharma Times)
  • US Pharmacy Won't Provide Drug for Execution (AP)
  • Compounding Pharmacies Called On To Make Execution Drugs (NPR)
  • Drug Shortages Exacerbated by Supply Chain Woes (Health Leaders Media)

US: Medical Devices

  • FDA Outlines Feedback Process For Medical Device Approvals (Law 360-$) (FDA)
  • Opponents say PROTECT Act could destroy mHealth, endanger patients (mHealthNews)
  • FDA's slow process hurts innovation: Column (USA Today)
  • Debate over FDA oversight of apps continues (Gov Health IT)
  • Industry, Consumers Seek Greater Clarity In Hearing Aid Draft Guidance (Gray Sheet)
  • Like a Bad Penny, Pre-MMA 180-Day Exclusivity Keeps Turning Up! (FDA Law Blog)
  • Speedier PMA for high-risk devices addressing unmet needs a key US FDA focus (Clinica-$)
  • Dr. Tom Fogarty: My balloon catheter wouldn't survive today's FDA (Mass Device)
  • Rumor mill: Apple wants to use sensors to detect heart attacks (MedCityNews) (Forbes) (Apple Insider)
  • Medtronic Heart Monitor Spots Stroke Dangers in Study (Bloomberg)
  • Molecular Diagnostics Are in a Rut. The Industry Needs the FDA (Xconomy)
  • Macy Catheter for Rectal Medication Administration Receives FDA Clearance (MedGadget)

US: Assorted And Government

  • HRI regulatory center weekly newsletter (PWC)
  • FDA to shift 1,000 workers to White Flint (Biz Journal)
  • Updating Guidance on Use of Voluntary Consensus Standards to Promote Smarter Regulation, Collaboration, and Technological Innovation (OMB)
  • Enforcement Report - Week of February 12, 2014 (FDA)
  • US Capitol Capsule: Rigid regulations harmful to US entrepreneurship, report charges (SCRIP-$)

Upcoming Meetings And Events

  • 12 February 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 13 February 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 14 February 2014: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Roll up, roll up! See the incredible shrinking NICE reform! (SCRIP-$)
  • PhRMA Wants EU Put On US's 'Priority Watch List' For Plans To Disclose Basic Safety Info About Drugs (Tech Dirt)
  • European Medicines Agency welcomes new Head of IT Development Department (EMA)
  • Committee for advanced therapies - election of new chair, overview of 2013 and looking ahead (EMA)
  • EU transparency window "ajar, not open", say campaigners (SCRIP-$)
  • France's MNSA Grants Temporary Approval to J&J/Pharmacylics' CLL Drug Ibrutinib (MNSA)
  • EU mHealth regulatory requirements and update: why the NO in innovation? (MedicalDevicesLegal)
  • Medtronic TOTAL Across Crossing Catheter Approved in EU (MedGadget)
  • Boston Scientific WallFlex Esophageal Stent Gains CE Mark For The Treatment Of Refractory Benign Esophageal Strictures (Boston Scientific)
  • Sanofi wins EU approval for NexGard chew against dog fleas (Reuters)
  • MSD Animal Health Receives Marketing Authorization from European Commission for BRAVECTO (fluralaner) (Business Wire)
  • Families hope 'Frankenstein science' lobby will not stop gene cure for mitochondrial disease (Guardian)
  • Germany's stance on pricing threatens drug firm profits (Reuters)
  • Advice on herbal-drug interactions not easy for lack of data, finds DTB (PJO)
  • Pharma doing better than most industries, says EU Commission (Pharma Times)

India

  • Medicines Made in India Set Off Safety Worries (NYTimes)
  • Gujarat Regulators Warn Companies About Criminals Impersonating the US FDA (PharmaBiz)
  • Indian policy on clinical research restrictive: US pharma companies (India Times)
  • DCGI to allow import of drug with residual shelf life less than 60% under special conditions (PharmaBiz)
  • Doctors association slams US for pressuring India on pharma patent laws (India Times)
  • Indian pharma companies to soon get GMP compliant as mandated by US FDA (Pharmabiz)
  • Indian habit of 'jugaad' helps reduce healthcare costs considerably (Economic Times)

Japan & China

  • Diovan generics approved in Japan for June launch (SCRIP-$)

Other International

General Regulatory And Interesting Articles

  • Pharma companies shouldn't conduct clinical trials: Peter C Gøtzsche (Business Standard)
  • Sensor Technologies That Solve Challenges for Medical Device Makers (Medical Design)
  • The Good-Luck Charm That Solved a Public-Health Problem (Atlantic)
  • Can 'Robotic' Pills Replace Injections?: Mir Imran, With Google Backing, Hopes to Change Diabetes Treatment (WSJ)
  • Japanese Institute Opens Investigation Into Its Stem-Cell Breakthrough (WSJ-$)
  • First biomarker could help boys at risk of major depression (Reuters)
  • Family With a Risk of Cancer Tries to Change Its Destiny (WSJ-$)

Regulatory Reconnaissance #258 - 18 February 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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