Article archive

FDA Issues Final Guidance on "Considerations When Transferring Clinical Investigation Oversight to Another IRB"

28/05/2014 15:38
    FDA has issued final guidance on “Considerations When Transferring Clinical Investigation Oversight to Another IRB.”  The guidance is now available on FDA’s...

Indian Government to spend Rs 3,000 crore to strengthen drug regulatory

22/05/2014 10:24
  The government will invest Rs 3,000 crore over the next three years in the pharma sector to strengthen the drug regulatory system in the country. "Strengthening the regulatory system is on our agenda. Indian regulators are aware that there is a gap in the regulatory system which needs to be...

Sun Pharma gets warning letter from USFDA

22/05/2014 10:03
    Click to Read the News   Warning Letter            

EMA Official Details Obstacles to Reaching Mutual Reliance on GMP Inspections

22/05/2014 09:50
European and U.S. regulators have made strides towards mutual recognition of quality inspections so that companies being inspected by one regulator would not have to face an inspection by the other, but setbacks still remain, a top European regulatory official said. The FDA and Europe have been...

US FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products and FDA Questions and Answers

22/05/2014 09:26
The USFDA has published “Guidance for Industry, ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers” in May 2014.  This guidance contains questions and answers from public comments generated during the drafting of “Guidance for Industry, ANDAs: Stability...

PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP)

22/05/2014 09:21
The PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP), which will enter into force on 1st June 2014. The PIC/S GDP Guide is based on the EU GDP Guide.   While the EU GDP Guide is legally binding in the EU/EEA, the PIC/S GDP Guide is a non-binding guidance document...

Draft on Process Validation by WHO

22/05/2014 09:02
  Draft Document: https://www.who.int/medicines/areas/quality_safety/quality_assurance/Process-Validation_QAS13-527Rev1_25032014.pdf?ua=1 Dated April 2014 the WHO published a proposal for a revision of appendix 7 (non-sterile process validation) as a supplementary to the Guidelines on Good...

Organic Impurities Testing: USP plans extensive Revision of General Chapters and Monographs

22/05/2014 08:56
Some time ago, the USP launched an initiative to update a number of pharmacopeial monographs and general chapters. In doing so, the organisation takes into account scientific and technological progress in pharmaceutical analytics. In the framework of this initiative, the USP expert panel...

Qualification of a Responsible Person for GDP- UK Gold Standard

21/05/2014 08:50
The new EU GDP Guideline requires that a Responsible Person for GDP has been named. In Chapter 2.2 it is defined that: "The wholesale distributor must designate a person as Responsible Person. The Responsible Person should meet the qualifications and all conditions provided for by the...

ANDA Checklist for Completeness and Acceptability

11/05/2014 13:54
ANDA Checklist for Completeness and Acceptability (Quarter 4, 2013) (PDF - 105KB)  The Office of Generic Drugs has revised the regulatory filing checklist for 2011 to enhance the ANDA review process. The attached PDF is a copy of the regulatory filing checklist with updates hi-lited in...
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