Regulatory Focus™ > News Articles > Regulatory Recon: Indian Manufacturers Critique Quality—of FDA Inspectors (11 December 2014)

Regulatory Recon: Indian Manufacturers Critique Quality—of FDA Inspectors (11 December 2014)

Posted 11 December 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Indian Manufacturers Critique Quality—of FDA Inspectors (11 December 2014)

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

In Focus: US

  • FDA OKs Gardasil 9 to Prevent Cancers Caused by Five Additional Types of HPV (FDA) (Fierce) (WSJ-$) (SCRIP-$) (AP)
  • Pharma Recalls Quiet in Q3 But More Companies Had Multiple Events (Stericycle)
  • 2014 Year In Review Of US Biosimilar Activity (Law 360-$)
  • Priority Review Voucher Bill Sent to President for His Signature (Congress)
  • Still Time To File: Potential NDA/BLA Candidates In Queue For 2014 (In Vivo-$)
  • FDA Plans to Consolidate its Pharmaceutical Import Districts (FDAnews)
  • Industry, FDA Start To Settle Into 510(k) Refuse-To-Accept Program (Gray Sheet-$)
  • Attorneys: ‘Proper Rulemaking’ Better Than Guidance For LDTs (Gray Sheet-$)
  • Healthcare industry groups seek compatibility standards for medical devices (Fierce)
  • Where was the dietary supplements industry at FDA's Redbook hearing? (NI-USA)

In Focus: International

  • Pharma Trade Group says bad inspectors making Indian manufacturers fear visits (In-Pharma)
  • Industry urges DCGI to treat all State-approved FDC drugs prior to 2008 as rational (PharmaBiz)
  • Stelara's Triumph At NICE May Highlight Improved Focus on Drug Value (Pink Sheet-$)
  • After initial doubts, generics firms join European anti-counterfeiting scheme (SCRIP-$)
  • Changes in the wing for IVD common technical specifications (Clinica-$)
  • Canadian Prescription drug ad law notable for 'lack of teeth' (CBC News)

US: Pharmaceuticals and Biotechnology

  • FDA OKs Gardasil 9 to Prevent Cancers Caused by Five Additional Types of HPV (FDA) (Fierce) (WSJ-$) (SCRIP-$) (AP)
  • Pharma Recalls Quiet in Q3 But More Companies Had Multiple Events (Stericycle)
  • 2014 Year In Review Of US Biosimilar Activity (Law 360-$)
  • Priority Review Voucher Bill Sent to President for His Signature (Congress)
  • Still Time To File: Potential NDA/BLA Candidates In Queue For 2014 (In Vivo-$)
  • FDA Plans to Consolidate its Pharmaceutical Import Districts (FDAnews)
  • Bioequivalence and the Problems With Narrow Therapeutic Index Drugs (Morning Consult)
  • DEA Creates New Electronic Certification Process for Controlled Substances Applications (DEA)
  • Update From the Office of Surveillance and Epidemiology (FDA)
  • FDA Drug Safety Communication: FDA reporting mental health drug ziprasidone (Geodon) associated with rare but potentially fatal skin reactions (FDA)
  • Determination That PFIZERPEN (Penicillin G Potassium) Injection, 1 Million Units/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
  • New Bioequivalence Guidance for Budesonide (FDA) (Guidance)
  • Therapeutic Equivalence Ratings Under 505(b)(2) (Camargo)
  • Worth Watching: Senator Warren on Warning Letters and FDA Enforcement (Senate)
  • Manufacturing Support for “Breakthrough Therapy” Designation for Solid Oral Dosage Forms (Camargo)
  • Life-threatening disease and the benefit-risk of treatment options (Pharma Letter-$)
  • Hepatitis C Drugs To Be Compared Under PCORI Study Grants (Pink Sheet-$)
  • FDA Issues Import Alert for Unapproved Follicle Stimulating Hormone Drugs for Cattle (FDA)
  • First Generic Versions of Celebrex Launched (MPR)

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

  • FDA gives approval for marijuana oil study (AP)
  • Shire's guanfacine hydrochloride extended release reduces core ADHD symptoms in Phase III trial (PharmaLetter-$)
  • Otsuka and Lundbeck’s Brexpiprazole Demonstrates Statistically Significant Effects in New Phase III Studies in Adult Patients with Schizophrenia (Press) (BioCentury)
  • Pfizer’s Lyrica Doesn’t Help Most Common Back Pain, Study Finds (Bloomberg) (Pain Report)
  • Phase III Results from German Breast Group (GBG) Demonstrates Superior Activity in High Risk Early Breast Cancer for Nab-Paclitaxel (ABRAXANE®) VS. Solvent-Based Paclitaxel (Press)
  • Neurovance Announces Top-Line Study Results Suggest Lower Abuse Potential for Centanafadine Compared to Stimulants Used for Adult ADHD (Press)
  • Vectura achieves positive results in Phase IIb/III trial of VR475 drug-device hybrid for asthma (PharmaLetter-$)

US: Pharmaceuticals and Biotechnology: General

  • Has developing new medicines got more lucrative? (CNBC)
  • Ohio lawmakers remove death penalty bill measure that could have led to drug shortages (Guardian)
  • EMD Serono launches app to help patients verify medicine (BizJournal)
  • Innovation Driving Positive Outlook for Pharma and Biotech in 2015 (Press)

US: Medical Devices

  • Industry, FDA Start To Settle Into 510(k) Refuse-To-Accept Program (Gray Sheet-$)
  • Attorneys: ‘Proper Rulemaking’ Better Than Guidance For LDTs (Gray Sheet-$)
  • Healthcare industry groups seek compatibility standards for medical devices (Fierce)
  • Your Medical Device Part Has Failed—Now What? (MDDI)
  • Medtronic Receives FDA Approval and Launches Two New Cardiac Resynchronization Therapy Quadripolar Leads (Press) (Mass Device)
  • Former Legislator: Time to advance a new oversight framework for health IT (The Hill)
  • Startup gains FDA clearance for breast surgery guidance system (Fierce)
  • Merit Medical Announces Multiple Regulatory Approvals (Press)
  • Quidel Receives FDA Clearance for Its AmpliVue Hand-Held Molecular Diagnostic Test for Bordetella Pertussis (Press)
  • FDA Approves New SONNET Audio Processor and MAESTRO 6.0 Software from MED-EL (Press)

US: Dietary Supplements

  • Where was the dietary supplements industry at FDA's Redbook hearing? (NI-USA)
  • Crisis management & communication for dietary supplements: Prioritize your audience and put the regulators at the top of the list, says expert (NI-USA)

US: Assorted And Government

  • FDA Gets Senate Funding, House Scolding In FY 2015 CR-Omnibus (Pink Sheet-$)
  • S.2988 -- Regulatory Cost Assessment Act of 2014 (Senate)

Upcoming Meetings

Ebola Outbreak

  • Ebola vaccine trial interrupted for checks after joint pains - Geneva hospital (Reuters)
  • Alliance set to buy millions of Ebola vaccine doses (AFP) (Bloomberg)

Europe

  • Stelara's Triumph At NICE May Highlight Improved Focus on Drug Value (Pink Sheet-$)
  • After initial doubts, generics firms join European anti-counterfeiting scheme (SCRIP-$)
  • Changes in the wing for IVD common technical specifications (Clinica-$)
  • New EU Internal Market and Industry Commissioner says parallel trade is lawful (PharmaLetter-$)
  • Putting the case for regenerative medicine (PharmaPhorum)
  • St. Jude Medical wins CE Mark for Quadra Allure MP pacemaker (Mass Device)
  • Gore lands CE Mark for Viabahn vascular device (Mass Device)
  • Amicus To Submit EMA For Migalastat Monotherapy In Fabry Disease (RTT)
  • GlaxoSmithKline Seeks Variation on Authorization for Ambrisentan (Press)
  • Amicus eyes a 2015 EU filing for its rare disease drug with FDA in sight (Fierce)

India

  • IPA says bad inspectors making Indian manufacturers fear visits (In-Pharma)
  • Industry urges DCGI to treat all State-approved FDC drugs prior to 2008 as rational (PharmaBiz)
  • No trial waiver for Sirturo in India (SCRIP-$)
  • Let India Make Cheap Drugs (NYTimes)

Japan

  • Emerging Markets Regulatory Tracker: Japan (Vol. 4 No. 77) (PharmAsia-$)
  • Soliris (eculizumab) Granted Orphan Drug Designation in Japan for the Treatment of Patients with Myasthenia Gravis (Press)

Canada

  • Canadian Prescription drug ad law notable for 'lack of teeth' (CBC News)

Australia

  • Australia Updates its Banking Services Information (TGA)
  • Australia Says Zimmer Triology Bone Screws can Fracture (TGA)

Clinical Trials

  • Discontinuation and non-publication of surgical randomised controlled trials: observational study (BMJ)
  • Old dogs and new tricks: The real-world consequences of excluding older adults from drug trials (BioWorld)
  • The Epic Failure to Achieve Diversity in Clinical Trials Persists (Thompson Reuters)
  • Risk-Based Monitoring Updates: TransCelerate, the Value of SDV, Global Monitoring Trends and More (MDsol)

General Regulatory And Interesting Articles

  • Recommended shorter breast-radiation treatment catching on slowly (Reuters) (NBC)
  • Cost of superbug resistance; $100 trillion and 10 million deaths (PharmaTimes)
  • Hair loss treatment may be dangerous to kids (Reuters)
  • Smart prosthetic skin can sense pressure, heat and moisture (MedCityNews)

Regulatory Reconnaissance #457 – 11 December 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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

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


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