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1. www.fda.gov › drugs › drug-approvals-and-databasesDrugs@FDA Data Files | FDA - U.S. Food and Drug Administration

   www.fda.gov › drugs › drug-approvals-and-databases

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   5 Δεκ 2023 · Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

   • Orange Book Information on Reference Standard

     An outline of data updates to "Approved Drug Products with...

2. www.fda.gov › media › 78941CDER 21st Century Review Desk Reference Guide - U.S. Food and...

   www.fda.gov › media › 78941

   Describe the steps and expected timelines for the review processes for the different types of applications. Provide a resource for CDER staff members. Describe the PDUFA V review model referred...

3. www.fdatracker.com › fda-calendarFDA Calendar - FDA Tracker

   www.fdatracker.com › fda-calendar

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   Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers companies publicly traded in the U.S. facing upcoming PDUFA dates.

4. www.rttnews.com › corpinfo › fdacalendarFDA Calendar, FDA Drug Approval, PDUFA Calendar - RTTNews

   www.rttnews.com › corpinfo › fdacalendar

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   Get daily updates on important FDA approval, PDUFA dates, and FDA Advisory Committee Meetings with RTTNews FDA Calendar & Upcoming Approvals.

5. www.fda.gov › drugs › drug-approvals-and-databasesApproved Drug Products with Therapeutic Equivalence Evaluations...

   www.fda.gov › drugs › drug-approvals-and-databases

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   11 Οκτ 2024 · Search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number. Jump to: Orange Book Publications ...

6. medicalsciences.stackexchange.com › questions › 24987How to find FDA's and EMA's review reports and related minutes

   medicalsciences.stackexchange.com › questions › 24987

   You can find review reports on EMA approved drug and regenerative medicine from here. Don't forget check On the "European public assessment reports (EPAR)" (See following Figure). For example, that of tamiflu (drug) and alofisel (regenerative medicine) are available from the following links. https://www.ema.europa.eu/en/medicines/human/EPAR ...

7. www.accessdata.fda.gov › drugsatfda_docs › ndaCENTER FOR DRUG EVALUATION AND RESEARCH - Food and Drug...

   www.accessdata.fda.gov › drugsatfda_docs › nda

   REQUIRED PEDIATRIC ASSESSMENTS. Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients (which includes new salts and new fixed combinations),...