Discussion Category - Part 2

New drugs would receive a conditional Notice of Compliance (NOC) based on a designated minimum of efficacy and safety data that could be less than the current requirement and would, therefore, be approved for marketing earlier than at present. It may be possible to implement such a scheme under the recent NOC with Conditions Policy, […]

These drawbacks were overcome in Wilson’s scheme and, subsequently, in prescription-event monitoring by using the United Kingdom Prescription Pricing Authority to identify patients from the names and addresses on prescriptions in the normal course of its work. A possible alternative method of identifying patients without influencing prescribing patterns is to select them from health care […]

All the proposals were designed to improve the identification of adverse drug reactions rather than evaluate effectiveness, but this element could have been added. It is included in prescription-event monitoring in a limited way by asking physicians whether the drug was effective or not . Although effectiveness was not their main focus, an examination of […]

As a result of the practolol experience, it was recognized that other active efforts were required to identify adverse reactions more consistently than is possible with passive voluntary systems. In particular, proposals were put forward for approving a drug for marketing on a conditional basis, during which time its use would be actively monitored for […]

Conditional release is the approval of a new drug onto the market, subject to specific conditions that, if achieved, will lead to full approval. The conditions may relate to effectiveness and/or safety but are not necessarily limited to these factors. The conditional approval for the marketing of a new drug, during which time the product […]