Tag: first generic filer
Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
The first generic drug company to file a patent challenge gets 180 days of exclusive sales rights. But this rule, meant to lower drug prices, is often manipulated-delaying competition and keeping patients from affordable medicines.
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Contamination controls in generic drug manufacturing prevent harmful residues and microbes from entering medicines. Learn how cleanrooms, real-time monitoring, and human factors impact drug safety-and what’s changing by 2025.
Published ON: 11 DecThe first generic drug company to file a patent challenge gets 180 days of exclusive sales rights. But this rule, meant to lower drug prices, is often manipulated-delaying competition and keeping patients from affordable medicines.
Published ON: 15 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 DecMethadone can prolong the QT interval on an ECG, raising the risk of life-threatening arrhythmias. Learn who’s at risk, when to monitor, and how to stay safe while in treatment.
Published ON: 8 DecLithium carbonate generics require careful serum level monitoring due to their narrow therapeutic window. Switching between brands can alter blood levels, risking toxicity or relapse. Learn safe targets, testing schedules, and how to avoid dangerous interactions.
Published ON: 1 Dec