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February 01, 2013
Adherence to GMP in API manufacturing is crucial in determining the safety of drug products.
January 15, 2013
FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance
January 08, 2013
Eli Lilly expects overall revenue growth in the coming year.
January 01, 2013
Siegfried Schmitt, a principal consultant with PAREXEL, discusses the EMA's guideline on process validation and how it compares with FDA's process validaton guidance.
Revalidation of cleanroom disinfection may be unnecessary, according to John S. Kent.
December 21, 2012
The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.
December 18, 2012
FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.
December 02, 2012
To ensure the accuracy of scientific testing, protect the subjects to avoid data contamination.
November 20, 2012
FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.
November 02, 2012
Even when all is well at the facility, one must expect the worst while braving the elements.