Tag: ANDA
Generic Drug Approval Standards: Safety, Quality, and Strength Requirements
29 Dec
|
12:58 PM
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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Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
15 Dec
|
11:52 AM
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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