Clinical trials face heightened scrutiny as science and commerce appear to merge

Journal of Biolaw and Business

Volumn 4, Issue 4, 2001, Pages 23-32

  Lorman, Alvin J ^a  

^a Law Firm Mintz Levin Cohn F ^*  (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL; COMMERCIAL PHENOMENA; GENE THERAPY; GOVERNMENT; HEALTH CARE ORGANIZATION; HUMAN; HUMAN RIGHTS; INFORMED CONSENT; LAW SUIT; MEDICAL RESEARCH; MEDICARE; PATIENT SELECTION; POLICY; REVIEW; SCIENCE; AGED; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CONFIDENTIALITY; DRUG INDUSTRY; ECONOMICS; FOOD AND DRUG ADMINISTRATION; FORGERY; GOVERNMENT REGULATION; HUMAN EXPERIMENT; INFORMATION PROCESSING; LEGAL APPROACH; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; PROFESSIONAL STANDARD; RESEARCH SUBJECT; SAFETY; STANDARD; UNITED STATES;

NEW DRUG;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

AGED; CLINICAL TRIALS; CONFIDENTIALITY; DRUG INDUSTRY; DRUGS, INVESTIGATIONAL; ETHICS COMMITTEES, RESEARCH; FRAUD; GOVERNMENT REGULATION; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MEDICARE; PATIENT SELECTION; RECORDS; RESEARCH SUBJECTS; SAFETY; UNITED STATES; UNITED STATES DEPT. OF HEALTH AND HUMAN SERVICES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0035686692     PISSN: 10955127     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (10)

1. No. 00-CR-5212-ALL (E.D. Ca., filed May 25, 2000).
2. See 21 CER. § 312.53 (c)
3. 18 U.S.C. § 1341
4. OEI-01-97-00195 (June 2000) available at www.hhs.gov/OIG/OEI
5. OEI-01-97-00196 (June 2000), available at www.hhs.gov/OIG/OEI
6. OEI-05-99-00350 (June 2000), available at www.hhs.gov/OIG/OEI
7. www.hhs.gov/OIG (OIG investigations)
8. www.clinical-trials.gov (NIH site on clinical trials)
9. www.fda.gov/oc/oha (PDA's clinical trial site)
10. http://ohrp.osophs.dhhs.gov (Office of Human Research Protection)