Agency IQ

JANUARY 26, 2024

In 2001, the American Medical Association (AMA) conducted a survey of relevant stakeholders – including PhRMA, the U.S. In some cases, manufacturers have determined that specific drug products have limited stability when the original packaging is opened. When such a situation is identified, it is noted in the product labeling.

Science 40

Science FDA Production Packaging 40

Agency IQ

JULY 12, 2024

In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. active pharmaceutical ingredient, fill/finish, packaging/labeling). Read AgencyIQ’s analysis of the non-paper.] points of disruption).

Regulations 40

Regulations Production Packaging FDA 40

Drug & Device Law

JANUARY 4, 2024

Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d 341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. 247d-6d(b)(8). “To

Vaccine 59

Vaccine FDA FDA Approval Production 59