FDA Commissioner speaks out on Innovation
06/01/2014 00:32
In a recent article FDA Commissioner Margaret Hamburg, M.D., talked about how Innovation is part of FDA’s mission.
Read the article here – https://1.usa.gov/19aw9uf
Article archive
My new Mobile Application "SRK CLEANING VALIDATION
01/01/2014 22:55
Hi Friends!
Welcome to SRK VALIDATION- CLEANING
We know that cleaning validation in GMP environment is a tough and evergreen topic for Manufacturers as well as Inspectors. On this topic if we have all the related guidelines, presentations, information etc. at one place and that too in...
MACO Calculation Sheet in Cleaning Validation
24/12/2013 22:02
Hi Friends!
Do you want a ready made MACO calculation sheet for Cleaning Validation? If Yes, take
MACO Calculation.xls (33792)
Most Frequent FDA 483 Observations Fiscal Year 2012
18/12/2013 00:44
Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s. Enclosed are the “top fifteen” Observations. The Observations within the top fifteen usually do not change — although their frequency and ranking may vary. Please note that the frequencies...
China arrests 1,300 people suspected of making and selling fake medicines
16/12/2013 00:25
Chinese police have rounded up more than 1,300 people nationwide suspected of producing and selling fake medicine, state media have reported.
Authorities seized fake drugs and nine tonnes of raw materials worth more than 2.2bn yuan...
Mumbai pharma summit to honour excellence, promote ethics
16/12/2013 00:06
Mumbai:
The stage is set for the 6th summit among doctors, drug makers and regulators here later this month that will not only discuss issues concerning the $17-billion Indian pharma industry but also honour top doctors and firms in 40 categories.
Organised by Network 7 Media Group’s Pharmaleaders,...
FDA Science and Research: Keeping stored platelets free of bacteria
15/12/2013 23:35
On 19 November, the FDA informed at their website about a publication in Transfusion 2013 Jun 30. doi: 10.1111/trf.12318.with the title "Preclinical safety evaluation of human platelets treated with antimicrobial peptides in severe combined immunodeficient mice".
The Authors, the FDA scientists...
ICH reviews future ICH topics and its Organisation
15/12/2013 23:31
The results of the International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) meeting in Osaka, Japan have been published.
The ICH SC furthered discussions on governance and increased engagement of regulators globally that had taken place in La...
New USP Requirements for Pharmaceutical Packaging Materials and International Standards for the Measurement of Material Permeability Indexes
15/12/2013 23:29
This year, the USP has already published many new requirements for pharmaceutical packaging systems in the Pharmacopeial Forum (PF). For instance, the revision of the following two General Chapters was proposed:
Container Performance Testing - New Proposal for USP General Chapter <671> (also...
Boston Scientific's Watchman stroke-fighting device wins overwhelming FDA panel support
15/12/2013 12:17
After an up-and-down development path, Boston Scientific ($BSX) gained a crucial second chance for its implant designed to help prevent strokes in atrial fibrillation patients. An FDA advisory panel has overwhelmingly endorsed the Watchman device for approval, potentially boosting its chances...
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