Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939?
By using the Drugs@FDA database, you can search for information about FDA-approved brand name and generic drugs and therapeutic biological products. The database includes most of the drug products approved since 1939 and has drug labels, patient information, approval letters, and other information for most drug products approved since 1998.
The increased requirement for combined chronic toxicity and fertility assessment of biologics has led to greater use of sexually mature non-human primates. Older animals have different needs compared to the younger, adolescent animals with which we are used to working. In addition, the establishment of sexual maturity requires additional parameter measurements, such as assessment of menstrual cycling, hormone analyses, and seminology. Changes in caging are required to reflect the social hierarchy inherent with the interaction of older primates, especially since subordinate animals mature later than their dominant peers. Provision of complex environmental stimuli also becomes a greater necessity. Due to the increased size and weight of older primates, handling becomes more of a potential source of stress and injury, to both animals and their handlers. Differential criteria for assessment of sexual maturity in primates are discussed.
Source: Developments in Life Sciences
The pre-IND phase of drug development is the foundation upon which all development-related activities (including registration) depend. It is, therefore, essential to give proper forethought and attention to this initial, all-important step of the drug-development process. In the United States, a pre-IND meeting can add considerable value to the overall process and maximize efficient use of both Sponsor and FDA resources. Although pre-IND meetings require considerable planning and preparation on the part of both the Sponsor and FDA, if warranted and properly conducted, the meeting can provide the Sponsor with valuable insight as to the FDA’s expectations regarding initial- and later-stage development and registration strategies. This presentation provides a high-level introduction to U.S. FDA pre-IND meetings ─ why and when a Sponsor should consider having a meeting and how the Sponsor approaches the process.
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About the Author:
Grace Furman, Ph.D.