By Margaret B. Liu, Kate Davis(auth.)
Chapter 1 classes from a Horse Named Jim and different occasions in heritage Affecting the legislation of scientific study (pages 1–11):
Chapter 2 the method: constructing New medicines, Biologics, and units (pages 13–48):
Chapter three stable scientific perform and the rules (pages 49–72):
Chapter four proficient Consent and the rules (pages 73–100):
Chapter five Institutional assessment forums (pages 101–121):
Chapter 6 hostile occasions and Unanticipated difficulties regarding hazards to topics or Others (pages 123–139):
Chapter 7 tracking, Audits, and Inspections (pages 141–162):
Chapter eight The relevant Investigator, the medical examine Coordinator, and the research website (pages 163–176):
Chapter nine The Protocol (pages 177–198):
Chapter 10 examine Feasibility: Reviewing a particular Protocol (pages 199–212):
Chapter eleven examine actions (pages 213–244):
Chapter 12 learn Documents/Essential records (pages 245–269):
Chapter thirteen administration of analysis medicines, Biologics, and units (pages 271–279):
Chapter 14 coping with medical Trial information (pages 281–311):
Chapter 15 worldwide healthiness and foreign Trials (pages 313–324):
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Additional info for A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition
The advisory committees to CDRH offer recommendations, but final decisions are made by FDA. Combination Products A new category of medical products is that of combination products, which have both drug and device actions.
Biologics, as their name suggests, are generally derived from living material – human, animal, or microorganism. Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product . . ” Considered a subset of drugs, biological products are regulated under provisions of the Food, Drug, and Cosmetic Act. Licensing of biologic products is very similar to the process for approving new drugs.
STEP 2: Determine the classification (I, II, or III), risk assessment (SR or NSR), and the appropriate marketing process (either Premarket Notification [510(k)] or Premarket Approval, unless exempt from both). STEP 3: Develop the data and/or information needed to submit the marketing application to obtain FDA clearance for marketing. Some [510(k)] submissions and most PMA applications require clinical trials conducted under IDE regulations. 1 regulated as new drugs before 28 May 1976; 2 found not substantially equivalent to devices marketed before 28 May 1976; or 3 that are Class III pre-amendment devices which require a Premarket Approval Application.
A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition by Margaret B. Liu, Kate Davis(auth.)