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CDERs Joseph Famulare cites recent statistics on drug recalls, and identifies specific problem areas in production and quality sys...[ Price : $8.95]
A scathing FDA untitled letter provides a glimpse into the troubles contract research organization MDS Pharma is having in trying ...[ Price : $8.95]
FDA plans a follow-up inspection of a Medtronic neurological devices manufacturing facility after the agency received limited info...[ Price : $8.95]
Retired FDA chemist Burton Appleton asks USP to help him appeal last months federal court loss to FDA on levothyroxine documents, ...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Actavis Totowa, Frye Health Systems, Hamricks, LGS Technologies, Medtronic, and ...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on drug interaction studies, which details study design and implications fo...[ Price : $8.95]
FDA approves a Mylan Pharmaceuticals ANDA for topiramate tablets, 25 mg, 100 mg and 200 mg, a generic version of Ortho-McNeil's To...