08/31/2018
Category: Good Industry Practices
Outside the pharmaceutical world, the concept of “pharmacovigilance” is rarely discussed or understood. In certain circumstances, the full conduct of pharmacovigilance may...
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08/29/2018
Category: Good Industry Practices
A literature review can be used to strengthen a human drug, biologic, or medical device product portfolio and their corresponding regulatory submissions....
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07/29/2018
Category: Regulatory
Establishment Registration and Product Listings Before discussion of the role of the FDA U.S. Agent, it is useful to understand Establishment Registrations...
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