FDA Issues Series of Guidances Under Drug Competition Action Plan

This week, FDA published a series of guidances focused on generic drug application submissions, labeling, and review

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Issues Series of Guidances Under Drug Competition Action Plan   This week, FDA published a series of guidances focused on generic drug application submissions, labeling, and review. These guidances are part of our continued efforts to bring greater efficiency and transparency to the generic drug review process, which helps spur competition and improves consumer access to the medicines they need at affordable prices. Bringing more competition to the market and addressing the high costs of medicines are top agency priorities. These guidances support FDA's Drug Competition Action Plan (DCAP), which encourages robust and timely market competition for generic drugs. Offering clarified, up-to-date guidance for industry demonstrates FDA's commitment to bringing more high-quality, safe, effective, and affordable generic medicines to all consumers.   Learn More The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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