Regulatory Focus™ > News Articles > Regulatory Recon: FDA Flags Manufacturing Troubles at India's Cadilla (31 July 2014)

Regulatory Recon: FDA Flags Manufacturing Troubles at India's Cadilla (31 July 2014)

Posted 31 July 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Flags Manufacturing Troubles at India's Cadilla (31 July 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

In Focus: International

  • EMA approves Eisai's request for accelerated assessment of lenvatinib in thyroid cancer (Pharma Letter-$) (Pharma Times) (Press)
  • Draft guideline on clinical evaluation of medicinal products used in weight control (EMA)
  • Germany appoints new head of BfArM from within the ranks (SCRIP-$)
  • Bigger changes to EU notified body code of conduct expected in Q4 (Clinica-$)
  • Novartis apologizes for not disclosing side-effects of leukemia drugs sooner (Reuters) (Pharmalot)
  • Canada Revises Clinical Trial Application Notification procedures (Health Canada)

US: Pharmaceuticals and Biotechnology

  • FDA raises concern over drug production process at India's Cadila (Reuters)
  • Is Valeant's Cost-Cutting Hurting its Relationship With FDA? (ProPublica)
  • New antibiotics pathways, rapid Dx dominate NIH-FDA forum (SCRIP-$)
  • FDA Changed Course On Zontivity Because Of Skepticism Of Subgroups At High Levels (PAM-$)
  • To Tweet or Not to Tweet? Or Even Retweet? FDA, Tweeting and Twitter (Eye on FDA)
  • FDA Increases Drug and Medical Device Imports Refusal Due to Improper Registration (Press)
  • USP weighs in on biosimilarity (BioCentury)
  • New FDA MAPP on Drug Development Tool Qualification Programs (FDA)
  • “Pedigree Nouveau” Must Be Uncorked January 1 (FDA Law Blog)
  • Hospira's Rocky Mount plant meets FDA goals, but one in India does not (Fierce)
  • New FDA draft consent form guidance omits patient data sharing (AllTrials)
  • FDA reviewers question HyQvia's benefit-risk profile (BioCentury) (MedCity News) (Reuters)
  • With Two Business Days Remaining in July, OGD has Only Approved 17 ANDAs (Lachman)
  • Pending Recall for Daiichi Sankyo; Drugs Weren't Stored at Correct Temperature (FDA)
  • Pending Recall for Sandoz; Stainless Steel Particles Found in API (FDA)
  • Accessing FDA Approval Packages and Briefing Documents (Sage)
  • Boehringer Sues Amneal To Block Generic Aggrenox (Law 360-$)

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

US: Pharmaceuticals and Biotechnology: General

  • NIH launches new program to find potential drug targets (NIH)

US: Medical Devices

  • J&J Unit Recalls Hysterectomy Device Over Cancer Fears (Law 360-$) (Mass Device) (WSJ-$) (Reuters) (Bloomberg)
  • FDA Panel Votes Down Ablatherm HIFU Device For Prostate Cancer (Gray Sheet-$) (Mass Device)
  • Consumer Groups Call for Reclassification of Surgical Mesh Products (Public Citizen) (Consumers Union)
  • Human Factors and Packaging: Adventures in Medical Device Usability (MDDI)
  • The Medical Device Is Safe, But Would I Use It? (MDDI)
  • Hospira focuses on devices with two new infusion pumps before FDA (Fierce)
  • Abiomed expects FDA nod for Impella sooner than forecast (Mass Device)
  • Unique Device Identifiers: Improving Patient Outcomes and Care (Pew)
  • U.S. Senate panel to look into price setting for contact lenses (Reuters)

US: Dietary Supplements

  • 'Health food' too broad for effective supplements regulation (NI-USA)

US: Assorted And Government

  • 3 Theories Why FDA Inspections are Down 25% (FDAzilla)
  • What Goes in to a Regulatory Cost Estimation? (The Hill)
  • FDA Enforcement Report Posted (FDA)
  • Former FDA'er Sharfstein to Join JHU (CBS)

Europe

  • EMA approves Eisai's request for accelerated assessment of lenvatinib in thyroid cancer (Pharma Letter-$) (Pharma Times) (Press)
  • Draft guideline on clinical evaluation of medicinal products used in weight control (EMA)
  • Germany appoints new head of BfArM from within the ranks (SCRIP-$)
  • Bigger changes to EU notified body code of conduct expected in Q4 (Clinica-$)
  • Medical device makers face new obstacles to European approval (Mass Device)
  • Can “Valid Evidence” be Subjective among HTAs? (Context Matters)
  • Contrave Obesity Pill Faces Manufacturing Questions In Europe (Pink Sheet-$) (Press)
  • Clearing the fog around Italy’s new IVD registration rules (Clinica-$)
  • NICE won’t back Revlimid in new setting (Pharmafile) (Pharma Times)
  • Lupin Readies Suit Over $54M Collusion Fine From EC (PharmAsia-$)

India

  • India terms US 'Special 301' process a unilateral measure to create pressure on countries to increase IPR (PharmaBiz)

Japan

  • Novartis apologizes for not disclosing side-effects of leukemia drugs sooner (Reuters) (Pharmalot)
  • Health Minister Urges JPMA To Prevent Valsartan Scandal Recurrence (PharmAsia-$)

Canada

  • Canada Revises Clinical Trial Application Notification procedures (Health Canada)

Other International

  • WHO proposes 'biological qualifier' system for biosimilars (BioCentury) (WHO)

General Regulatory And Interesting Articles

  • Where are tomorrow’s biosimilar hotspots? (BioPharma Reporter)
  • Blood test could predict risk of suicide (WaPo)
  • Drug-resistant malaria reaches Southeast Asia borders, could spread to Africa (Reuters)

Regulatory Reconnaissance #369 – 31 July 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.


Categories: Recon, Regulatory News

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