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Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

FDA is enhancing one of the agency’s most viewed databases for industry, the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on “brand” drug products (180-day exclusivity).

Original source: http://www.fda.gov/news-events/press-announcements/statement-new-effort-improve-transparency-and-predictability-generic-drug-applicants-help-increase

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