Skip to main content
U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Search help
5,138 results
  1. NLM Digital Collections - Conduct of clinical trials of medical products during the COVID-19 public health emergency : .... 
    Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021
    resource.nlm.nih.gov/9918248910206676
    ... Updated on August 30, 2021 For questions on clinical trial conduct during the COVID-19 pandemic, please email Clinicaltrialconduct- ... important. IV. Additional Resources For further questions on clinical trial conduct during the COVID-19 public health emergency, please ...
  2. NLM Digital Collections - Fundamentals of the prescription drug market 
    Publication: Washington, D.C. : National Health Policy Forum, [2004]
    resource.nlm.nih.gov/101243309
    ... drugs. Generic drug manufacturers do not have to conduct clinical trials and prove safety and efficacy the way brand ... from the FDA, which allows the sponsor to conduct human studies. Controlled clinical trials (that is, human studies) are designed to assess ...
  3. NLM Digital Collections - E6(R2) good clinical practice : integrated addendum to ICH E6(R1) 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
    resource.nlm.nih.gov/101734075
    ... conjunction with other ICH guidances relevant to the conduct of clinical trials (e.g., E2A (clinical safety data management), E3 ( ... Regulatory Requirement(s) Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. 1.5 Approval (in relation ...
  4. NLM Digital Collections - Microdose radiopharmaceutical diagnostic drugs : nonclinical study recommendations 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
    resource.nlm.nih.gov/101734405
    ... is intended to help sponsors facilitate the timely conduct of clinical trials, reduce the use of animals with the 3R ( ... schedule the nonclinical studies to facilitate the timely conduct of clinical trials (including appropriate safety monitoring based on findings in ...
  5. NLM Digital Collections - Annual report - National Eye Institute (1981) 
    Publication: [Bethesda, Md.] : National Eye Institute
    resource.nlm.nih.gov/7802080X10
    ... Arthritis, Diabetes, Digestive and Kidney Diseases on the conduct of clinical trials. In March 1981, NIH held the International symposium " ... 20. Ederer F: Jerome Cornfield's contributions to the conduct of clinical trials. In Proceedings of Curr ent Topics in Biostatistics ...
  6. NLM Digital Collections - 7/2/1986-11/12/1986 
    https://resource.nlm.nih.gov/101637321X33
    ... to 14 medical centers in 8 states, to conduct clinical trials of experimental agents in the treatment of AIDS ( ...
  7. NLM Digital Collections - Briefing Book, 1989-1990 
    https://resource.nlm.nih.gov/101083016X51
    ... compounds from different sources. The pharmaceutical industry also conducts clinical trials through its system of privately sponsored testing. The ... utility in their =\ civing compounds from different s'sg conducts clinical trials through sreatest extent possible, trials should . for drug ...
  8. NLM Digital Collections - Human Immunodeficiency Virus (HIV), 1987-88 
    https://resource.nlm.nih.gov/101083016X22
    ... CSGs) are organized and supported by NIAID to conduct clinical trials of safety and efficacy of potential AIDS therapies. ... with live HIV. Physicians should be recruited to conduct clinical trials. Community-based centers for clinical investigations should be ...
  9. NLM Digital Collections - Chronic hepatitis C virus infection : developing direct-acting antiviral drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
    resource.nlm.nih.gov/101719919
    ... toxicology studies as part of an IND to conduct combination clinical trials. However, usually no more than two drugs should ... industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals and S6(R1) ...
  10. NLM Digital Collections - Drugs for Opportunistic Infections in Persons with HIV Disease (Hearing before House ... 
    https://resource.nlm.nih.gov/101083016X171
    ... 8, HIV/AIDS reaearchero havo been slow to conduct clinical trials In childran, This hac deprived children with proven ... adequate promise. ACT UP Demands The ACTG must conduct clinical trials on 30 new drugs each year. The Facts ...
first · previous · 1 · 2 · 3 · 4 · 5 · 6 · 7 · 8 · 9 · 10 · next · last