New Media for Product User Manuals

In 2017, the FDA created its Competent Generic Drugs (CGD) program to encourage the development of generic versions for off-patent drugs with no competition. This was in response to a widespread practice in the industry where a monopoly for a product allowed the manufacturer of such drugs to gouge the prices of their product with … Read more

New Way to Submit DeNovo Medical Device Requests

India is the source of many traditional, alternative, and herbal medicines including Ayurveda, Unani, and Homoeopathy. Although these medicines are mostly sold in India, a significant amount is exported to the US; almost 25% of all traditional medicines exported from India are destined to the US. FDA is aware that while none of these medicines … Read more