Found 14 datasets matching "cder".
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Department of Developmental Services (DDS) consumer population by diagnosis and regional center as reported on the Client Development Evaluation Report (CDER). Information reported by Regional...
Search relevance: 55.36 | Views last month: 29 -
Companies are required under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as amended by the Food and Drug Administration Safety and Innovation Act) to notify FDA of a...
Search relevance: 36.59 | Views last month: 19 -
The Drug Establishments Current Registration Site (DECRS) is a database of current information submitted by drug firms to register establishments (facilities) which manufacture, prepare,...
Search relevance: 36.51 | Views last month: 114 -
The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with...
Search relevance: 35.04 | Views last month: 88 -
Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that sponsors conduct after...
Search relevance: 35.04 | Views last month: 3 -
Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of the drug products approved since...
Search relevance: 33.81 | Views last month: 1001 -
This contains information that identifies clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug (IND) studies...
Search relevance: 33.36 | Views last month: 0 -
Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products.
Search relevance: 33.05 | Views last month: 60 -
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safety and...
Search relevance: 32.93 | Views last month: 20 -
The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated,...
Search relevance: 32.62 | Views last month: 194 -
For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution methods presently...
Search relevance: 32.62 | Views last month: 20 -
The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug...
Search relevance: 32.62 | Views last month: 3 -
According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final dosage forms of drug products...
Search relevance: 32.20 | Views last month: 44 -
The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's...
Search relevance: 31.30 | Views last month: 98
