New Drug Policy

Policies and Procedures MAPP No. 6030.1, dated May 1, 1998. This document provides the general review principles for investigational new drugs, policies, and procedures for issuing and overseeing clinical holds of INDs and policies and procedures for processing and responding to sponsors complete responses to clinical holds. 

The FME s emphasis on universal access pointed policies towards essential medicines, especially public health priorities such as antibiotics. Combined with process patents and price controls, it induced competition and Indian production capabilities in both public and private sectors. The SME saw the introduction of the strongly worded New Drug Policy (NDP) (Government of India, 1978). However, the NDP presumed that item (5) below was necessarily at the right position and compatible with the other goals set out as ... 

Government of India (GOI) (1978) New Drugs Policy, Ministry of Chemicals and Fertilisers, New Delhi. 

FDA s Policy Statement on the Development of New Stereoisomeric Drugs (Stereoisomeric Drug Policy) Fed. Regist. (1992) 57 FR22249. 

In the near future new drugs for the treatment of Alzheimer s disease are expected to be licensed, and it would be extremely valuable to be able to compare them in a clear and well-defined framework. In addition, if economic evaluation is to inform health and social care providers and policy-makers about the potential impact of new interventions in practice, estimation of the value for money of these new interventions requires consideration of (a) the perceived and objective risks and benefits of care (b) attitudes of people with... 

While we cannot predict how these policies will play out in the years ahead, they will dramatically influence innovation, positively or negatively, in the future and the pharmaceutical industry that depends on innovation and the consequent supply of new drug products that depends on the pharmaceutical industry. 

Goldstein A (1994). Addiction from Biology to Drug Policy. W.H. Freeman, New York. Grahame-Smith DG and Aronson JK (1992). Oxford Textbook of Clinical Pharmacology and Drug Therapy. Oxford University Press, Oxford, UK. 

Unfortunately, since drug problems have created strong opinions in this country, many opinions are slow to change even when they are inconsistent with the most recent scientific research. As a result, there is a wide array of new research that remains unknown by people who develop drug policies, who treat people... 

Second, FDA had to confront the fact that prior to the 1962 Amendments it had issued hundreds of old drug opinion letters for generic versions of pioneer new drugs. It, therefore, issued a statement of policy in May 1968 revoking all of those opinions. ... 

The FD C Act has been interpreted by FDA as applying only to the labelling, advertising and marketing of a new drug, not to the practice of medicine as reflected in the physician s prescription of the drug for a particular patient. In a policy first published in 1972 and reiterated many times, the FDA has stated that the physician may, within the practice of medicine, lawfully prescribe an approved drug for... 

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