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Revision of GMP Data Integrity Definitions from MHRA

03/04/2015 00:02
Medicines, medical devices and blood regulation and safety – guidance Good manufacturing practice: data integrity definitions Medicines and Healthcare products Regulatory Agency (MHRA) good manufacturing practice data integrity expectations for the pharmaceutical industry. Document: Revision 1.1...

New Guidance on Environmental Assessments for Biotechnology Products by USFDA

03/04/2015 00:01
  USFDA Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products   Background   Under 21 CFR 25.40 of the Code of Federal Regulations, most pharmaceutical...

EU Commission released two final Guidelines on GMP for Excipients and GDP for APIs

03/04/2015 00:00
After nearly two years of consultation, the European Commission has published two important and long-awaited guidelines in the official journal of the European Union, edition 21st March 2015:   The "guidelines on the principles of good distribution practice for active substances of medicinal...

Health Canada Vanessa's Law, effective from November 2014

03/03/2015 00:24
Introduction: Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) Amendments to the Food and Drugs Act (Bill C-17)   On December 6, 2013, the Government of Canada introduced the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). On November 6, 2014 it...

EudraLex V30 - January 2015

14/02/2015 13:18
   Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine.The Eudralex V30 is similar to the EudraLex section of this web site, but it can be used off-line with the search engine. All the documents are in.pdf...

USFDA Warning Letters- Drugs Updates

14/02/2015 13:11
Apotex Research Private Limited: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm432709.htmMicro Labs Limited:https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm431456.htm

Man gets 3-year prison sentence for fake drug study

14/02/2015 13:06
A clinical drug trial coordinator - who used his own stool samples for a drug study and pocketed the money earmarked for stool donors - received a three-year prison sentence in federal court Tuesday.Assistant U.S. Attorney Maureen Merin recalled in court how Wesley McQuerry, 50, created fake...

MHRA Warns of People Impersonating its Staff

14/02/2015 13:02
News storyImpersonation of MHRA staffFrom:Medicines and Healthcare Products Regulatory AgencyFirst published:11 February 2015Part of:Protecting patients from avoidable harm, National Health Service and Public health We are aware of telephone calls made to a company recently from an individual who...

FDA Commissioner Margaret Hamburg to Resign Next Month

14/02/2015 12:49
  Margaret Hamburg, one of the  longest-serving commissioners in US Food and Drug Administration (FDA)  history, plans to announce her resignation tomorrow, FDA officials have  confirmed to Regulatory Focus.  Hamburg's final day at the  agency will be in late March...

Concept paper on the revision of EU GMP Annex 1– manufacture of sterile medicinal products

14/02/2015 12:43
At the beginning of February 2015, the European Medicines Agency (EMA) published a Concept Paper on the revision of Annex 1. Annex 1 of the EU GMP Guide is the Guideline for Europe which describes the requirements on the manufacture of sterile dosage forms. The reasons given for the revision are...
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