Article archive

Quality Metrics: Industry Reaction to FDA's Draft Guidance

09/09/2015 23:15
On Monday, the US Food and DrugAdministration (FDA) held a public meeting to discuss its plan to requestquality metrics from drug manufacturers. The meeting was the first opportunityfor the agency and industry to publicly discuss the plan since FDA released itsdraft guidance in July.While many...

Recent Non-compliance Reports Published by EudraGMDP

28/07/2015 22:27
Recent non-compliance reports published by EudraGMDP:PARABOLIC DRUGS LIMITED (India)- Issued on 28 July 2015WUXI JIDA PHARMACEUTICAL CO., LTD (China)-  Issued on 28 July 2015JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD. (China)-  Issued on 28 July 2015INTEGRA LIFE SCIENCES CORP (US)-...

New Draft Guidance from USFDA on 'Request for Quality Metrics

28/07/2015 21:55
This guidance document is being distributed for comment purposes only. Comments andsuggestions regarding this draft document should be submitted within 60 days ofpublication in the Federal Register of the notice announcing theavailability of the draft guidance. Submit electronic comments to...

Update of Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2015) [EudraLex - Volume 2]

28/07/2015 21:16
EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use.Volume 2 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory...

New final Guidance from USFDA related to Pharmaceutical Quality/CMC on 'Analytical Procedures and Methods Validation for Drugs and Biologics

28/07/2015 21:05
Introduction: This guidance supersedes thedraft of the same name that published on February 19, 2014 (79 FR 9467) andreplaces the 2000 draft guidance for industry on Analytical Procedures and MethodsValidation and the 1987 Guidelines for Submitting Samples and Analytical Datafor Methods...

USFDA published a final rule (FDA-2011-N-0898 Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products)

28/07/2015 20:10
Drugshortage has become a serious problem. Besides problems in the distributionchain, reasons could be manufacturing and quality problems, delays, anddiscontinuations. The U.S. Food and Drug Administration (FDA) takes more andmore efforts to address and prevent drug shortages. In the case of...

Notice by CDSCO regarding administrative action by concerned licensing authority (Dated 04/06/2015)

14/06/2015 16:08
A notice was released recently by DCGI regarding following anequivalent administrative action, taken by licensing authority of otherconcerned country, in India also. A detailed assessment of impact due to this notice may be required to carry outby Indian Pharmaceutical industry.Notice

New WHO TRS 992 (May 2015) having guidance on Hold time study, Process validationand stirage & transport of products

14/06/2015 15:58
WHO TRS (T e c h n i c a l  R e p o r t  S e r i e s) 992 was released in May-2015 by WHO. This TRS has someuseful guidelines on the following topics as annexure. Out of these annexure,annex 3 (Guidelines on good manufacturing practices: validation, Appendix 7: non‑sterile process...

USFDA Draft Guidance on "Conditions: Reportable CMC Changes for Approved Drug and Biologic Products" Effective from 29 May 2015

02/06/2015 23:59
INTRODUCTION: This guidance has been developed to address the lackof clarity with respect to what chemistry, manufacturing, and controls (CMC)information in a marketing application constitutes an established condition ora "regulatory commitment" that, if changed following approval,...

USFDA Guidance on "ANDA Submissions- Refuse-to-Receive Standards" Effective from 26 May 2015

02/06/2015 23:53
 INTRODUCTION: This guidance is intended to assist applicants preparing to submitto FDA abbreviated new drug applications (ANDAs) and prior approval supplements(PASs) to ANDAs for which the applicant is seeking approval of a new strengthof the drug product. The guidance highlights...
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