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2. ClinicalTrials.gov - Wikipedia

   en.wikipedia.org/wiki/ClinicalTrials.gov

   As a result of pressure from HIV-infected men in the gay community, [citation needed] who demanded better access to clinical trials, the U.S. Congress passed the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) [2] which mandated the development of a database of AIDS Clinical Trials Information Services (ACTIS). [3]

3. List of Guidances for Statistics in Regulatory Affairs

   en.wikipedia.org/wiki/List_of_Guidances_for...

   FDA: Clinical trial endpoints for the approval of cancer drugs and biologics [17] provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications.

4. Investigational New Drug - Wikipedia

   en.wikipedia.org/wiki/Investigational_new_drug

   The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

5. US FDA recommends steps to improve diversity in clinical trials

   www.aol.com/news/us-fda-recommends-steps-improve...

   (Reuters) -The U.S. Food and Drug Administration on Wednesday recommended steps for drugmakers and medical device makers to improve racial, ethnic and other diversity in their clinical trials.

6. U.S. FDA places clinical hold on Biomea's diabetes trials

   www.aol.com/news/u-fda-places-hold-biomeas...

   The drug, BMF-219, was being tested in an early-to-mid stage study for type 2 diabetes and a mid-stage study in type 1 diabetes. The drug developer said the FDA cited deficiencies based on the ...

7. Center for Drug Evaluation and Research - Wikipedia

   en.wikipedia.org/wiki/Center_for_Drug_Evaluation...

   The FDA requires a four-phased series of clinical trials for testing drugs. Phase I involves testing new drugs on healthy volunteers in small groups to determine the maximum safe dosage. Phase II trials involve patients with the condition the drug is intended to treat to test for safety and minimal efficacy in a somewhat larger group of people.