PhRMA, BIO and The Pew Charitable Trusts have banded together to ask Congress to include language in the fiscal 2018 appropriations bills to clarify the FDA’s power to regulate compounding pharmacies. Read More

The FDA highlighted two fictional case studies it published on the role biomarker qualification plays in drug development — as part of a reorganization of the agency’s biomarker materials — to help drugmakers understand the validation studies necessary to support qualification, the collaborative efforts involved and the potential benefits. Read More

The FDA is seeking comment on a proposal to study how advertising disclosure statements and drug promotion affect consumers. Read More

The EMA says it will continue to invite patients to in-person discussions between reviewers and product sponsors — following a successful two-year pilot project involving five medicines. Read More

The European Medicines Agency has issued a new draft guideline on reporting breaches of clinical trial protocols. Read More

The European Medicines Agency named five treatments as eligible for its priority medicines program, bringing the total to 25. Read More