The need for greater involvement of regulatory agencies in assessing adverse drug reactions.
Year: 2000
Type: article
Abstract: Before a new drug is licensed for clinical use its effi-cacy and safety are rigorously assessed by govern-ment regulatory agencies. Summaries of results are not accepted by these agencies, and the simple submission of a manuscript, published in even the most prestigious of journals, will not suffice. The primary data must be available for detailed review. The scientific process, as it usually oper-ates in the review of manuscripts, is not considered to be sufficiently precise and detailed for the licensing of medica-tions. But when concern about a drug’s side effects is pub-lished, there is rarely an independent review of the primary scientific evidence because the regulatory agencies and pharmaceutical companies must act fast to protect the pub-lic. Therefore, the review of the data leading to the with-drawal of a medication is much less rigorous than the review of the data required for its approval. The example of Bendectin in the 1980’s established that
Source: Europe PMC (PubMed Central)
Author: A D Sniderman
Institution: McGill University
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W2141457432