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Pharmaceutical Manufacturing: FDA Report on Drug Shortages

Discover the FDA s 2023 report on drug shortages in pharmaceutical manufacturing. Learn about causes, impacts, and initiatives to mitigate shortages.
http://resources.pharmalinkage.com/industry-news/fda-highlights-ongoing-drug-shortages-report-and-its-implications/ - Details - Similar

Drug Companies: FDA User Fees FY 2025 Rates Updates

Drug companies: Check the FDA s FY 2025 user fee rates for drugs, biosimilars, medical devices, and OTC monographs. See new fees and changes.
http://resources.pharmalinkage.com/industry-news/fda-announces-new-user-fee-schedule-for-fy-2025-drug-companies/ - Details - Similar

Understanding FDA's FSVP Rule (Foreign Supplier Verification Program)

Many of you may have heard that FDA is starting to implement a new program called Foreign Supplier Verification Program (FSVP).
https://www.accb.us/single-post/2017/10/04/understanding-fdas-fsvp-rule-foreign-supplier-verification-program - Details - Similar

Top 7 Queries Addressed: Data Integrity and CGMP Compliance

This article provides a clear insight into the significance of data integrity within the framework of current good manufacturing practice
https://amplelogic.com/data-integrity-and-cgmp-compliance/ - Details - Similar

Regulatory One

http://www.regulatoryone.com/ - Details - Similar

Safety Labeling Changes (SLC), Drug Safety Labeling Changes

Masuu Global offers expert Safety Labeling Changes (SLC) services for USFDA-approved products, ensuring compliance and timely updates.
https://www.masuuglobal.com/labeling-artwork/safety-labeling-changes-slc/ - Details - Similar

Regulatory One: GDUFA AND ITS CONSEQUENCES

Thanks a lot for your feed back, Manikanta. Appreciate it!
http://www.regulatoryone.com/2013/03/gdufa-and-its-consequences.html - Details - Similar

Regulatory Review, Authoring Dossier Compilation Services

Masuu Global s regulatory review, authoring, and dossier compilation services for global health authorities, including US ANDA, NDA, BLA more.
https://www.masuuglobal.com/regulatory-affairs/review-authoring-dossier-compilation/ - Details - Similar

FDA Encourages the Public to Follow Established Choking Rescue Protoco

These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.
https://www.fda.gov/medical-devices/safety-communications/fda-encourages-public-follow-established-choking-rescue-protocols-fda-safety-communication - Details - Similar

Advisory Committees | FDA

Information about FDA public advisory committees, calendar of meetings, meeting materials, how to become an advisory committee member, guidance, and frequently asked questions.
https://www.fda.gov/advisory-committees - Details - Similar

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