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CARES Act Submission, FDA CDER NextGen portal, CARES Act

Masuu US Agent offers expert CARES Act submission help, ensuring accurate CSV reporting via the FDA CDER NextGen portal for compliance.
https://masuuglobal.com/associate-regulatory-services/cares-act-submission-assistance/ - Details - Similar

Drugs | FDA

The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States
https://www.fda.gov/drugs - Details - Similar

Electronic Common Technical Document (eCTD) | FDA

Electronic Common Technical Document (eCTD) mandatory use for some submissions starts May 2017. eCTD is the standard format for electronic reg submissions.
https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd - Details - Similar

Masuu US Agent: Pre-Assigned Application Numbers Tracking

Masuu US Agent aids foreign pharma in obtaining pre-assigned application numbers (ANDA, NDA, BLA) via the USFDA’s CDER NextGen portal for smooth tracking.
https://masuuglobal.com/associate-regulatory-services/application-number-assignment/ - Details - Similar

Masuu US Agent: Pre-Assigned Application Numbers Tracking

Masuu US Agent aids foreign pharma in obtaining pre-assigned application numbers (ANDA, NDA, BLA) via the USFDA’s CDER NextGen portal for smooth tracking.
https://www.masuuglobal.com/associate-regulatory-services/application-number-assignment/ - Details - Similar

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

Regulatory One: Webinars by FDA Personnel

http://www.regulatoryone.com/p/webinars-by-fda-personnel.html - Details - Similar

COVID-19 Home

The California Department of Public Health is dedicated to optimizing the health and well-being of Californians
https://covid19.ca.gov/ - Details - Similar

Warning Letters | FDA

The .gov means it’s official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters - Details - Similar

Global Pharma: Key Market Developments in the Generic Drugs

Key market developments in the generic drugs segment within the global pharma. It s challenges and opportunities shaping the future of generic drugs.
http://resources.pharmalinkage.com/industry-news/key-market-developments-in-the-generic-drugs-segment/ - Details - Similar

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