Αποτελέσματα Αναζήτησης
25 Οκτ 2023 · Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.
- Interstitial Cystitis/Bladder Pain Syndrome
Dockets Management Food and Drug Administration 5630 Fishers...
- Nonclinical Information
FDA has received an increasing number of questions regarding...
- Interstitial Cystitis/Bladder Pain Syndrome
In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA's Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs...
The table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product,...
27 Φεβ 2022 · In 2021, the US Food and Drug Administration (FDA) approved 50 novel drugs. Thirty-seven of the 50 (74%) novel drug approvals were reviewed and approved through an expedited review pathway, and 26 of the 50 (52%) were approved for treatment of a rare disease.
9 Φεβ 2024 · The FDA granted priority review designation to 695 (51.3%) drugs, including 15 (1.1% of total approvals) drugs approved using a priority review voucher and 19 (1.4%) drugs granted the Qualified...
RIDGEFIELD, Conn. and INDIANAPOLIS, November 11, 2021 – The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Jardiance® (empagliflozin) 10 mg, which is being investigated as a potential new treatment to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure ...
26 Ιουν 2023 · Data analysis was performed between October 28 and November 11, 2022. From 2017 to 2019, the FDA approved 107 therapeutics for 146 supplemental new indications, including 99 small molecule drugs (67.8%) and 47 biologics (32.2%) (Table).
