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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Laura Bush is a former managing editor of Pharmaceutical Technology and Editor-in-Chief of BioPharm International.
November 03, 2005
New FDA Guidance on Electronic Common Technical Document Submissions
November 02, 2005
Oddly for a technical meeting, the Oct. 5–7 AAPS Workshop on Pharmaceutical Quality Assessment focused on words, with an entire session devoted to definitions and countless discussions of meaning and nuance.
October 06, 2005
Collaboration Targets Single-Shot Japanese Encephalitis Vaccine
October 02, 2005
For years, pharmaceutical manufacturers have complained that federal regulations impede process improvements. Now, FDA is trying to do something about it.
The translator strives for quality, for a flawless re-setting of ideas from language to language. It is precise, painstaking work, making sure that all the concepts are there, that the grammar and syntax are correct, that the register (the formality, the emotional and social tone) is accurate, and that the text reads smoothly.
August 02, 2005
In 1987, when the US Food and Drug Administration issued its Guideline on General Principles of Process Validation, a young FDA reviewer asked her supervisors.