USP announced late Monday that it will not develop new product-specific monographs for biologics unless there is stakeholder consensus supporting the creation of a specific monograph, including the ...
JD Supra: USP States That It Will Not Revise Biologics Monographs Without Stakeholder Consensus
USP stated last week that it will not develop new product-specific monographs for biologics without stakeholder consensus in supporting their creation, including the support of FDA. USP had proposed ...
USP States That It Will Not Revise Biologics Monographs Without Stakeholder Consensus
USP’s efforts to develop biological product monographs could impede or delay licensure of biosimilars and other biologics, Janet Woodcock, director of FDA’s Center for Drugs Evaluation and Research, ...
USP's guideline for pending monographs can speed up publication of monograhs and time to market. Guideline for Pending Monographs allows development and online publication of monographs for certain ...
Metrohm USA is proud to partner with the United States Pharmacopeia (USP) and host a webinar describing the USP monograph modernization program and the impact of this program for analytical ...
WSOC-TV: Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Fluconazole Injection, USP, (in
Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg per 100mL flexible container bag (NDC ...
Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Fluconazole Injection, USP, (in
Fluconazole is a prescription antifungal used to treat yeast and fungal infections like thrush, vaginal candidiasis, and cryptococcal meningitis in various body sites.