American Academy of Pediatrics’ legislative proposals for user fee bill also include eliminating automatic orphan drug exemption from Pediatric Research Equity Act study requirements.
The American Academy of Pediatrics (AAP) wants to make pediatric study exemptions and delays harder to come by in legislation reauthorizing the US FDA’s drug user fee programs.
The professional organization is working on changes aimed at getting voluntary pediatric studies conducted under the Best Pharmaceuticals for Children...
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.
The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
