Tag: drug quality
Generic Drug Approval Standards: Safety, Quality, and Strength Requirements
Generic drugs must meet the same safety, quality, and strength standards as brand-name drugs. The FDA ensures this through strict bioequivalence testing, manufacturing inspections, and rigorous review of every application before approval.
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Multiple myeloma causes severe bone damage in over 80% of patients. Learn how new drugs are shifting from preventing bone loss to actually healing fractures - and what patients need to know now.
Published ON: 20 DecGlobal pharmacovigilance harmonization is improving drug safety by aligning reporting standards across countries. Learn how ICH guidelines, AI, and real-world data are reducing delays and saving lives - and where the system still falls short.
Published ON: 4 DecReplicate study designs are essential for assessing bioequivalence of highly variable drugs. Learn how full and partial replicate methods reduce sample sizes, meet regulatory standards, and improve generic drug approval rates.
Published ON: 2 DecPatent exclusivity and market exclusivity are two different legal tools that protect new drugs. One comes from the patent office, the other from the FDA. Understanding the difference explains why drug prices stay high-and who controls when generics arrive.
Published ON: 10 DecLearn the essential documentation requirements for recording generic drug substitutions in pharmacy practice. Understand state laws, what to log, common mistakes, and how to avoid errors that impact patient safety.
Published ON: 1 Dec