Why The US FDA Did Not Appreciate Valisure’s Extra Measure Of Protection From Poor Quality Drugs

Pharmaceutical manufacturers encouraged the FDA to consider including expansions and modifications of existing US drug facilities in the PreCheck program.

In a strongly-worded broadside against efforts to water down the EU’s Critical Medicines Act, the off-patent industry body Medicines for Europe has criticized the “selfishness” of certain actors who prioritize lower prices at the expense of supply security.

Actions taken by the European Commission and European Medicines Agency to tackle critical shortages of medicines have not succeeded in practice and further systemic improvements are required to address supply issues, a report from the European Court of Auditors has found.

Legal and other experts discuss the need to plug data privacy and regulatory gaps and address prescription shortcuts at e-pharmacies. Collaborative models with brick and mortar chemists were also proposed.