Day: August 24, 2017

In a new guidance document released by FDA practically every party that is involved in any aspect of the manufacture, distribution, shipping and handling of drugs and biologics will be required to register either with the FDA directly or with a state regulators where they operate. Several new parties are added to the registration requirements … Read more

DTC ads using social media are essential for marketing of a new drug and celebrity endorsements are a necessary component of it, particularly if the target population is broad. A company can reach a much wider audience using a recognized name. However, these endorsements frequently cross the fine line between FDA allowed communication and off-label … Read more