Millions of Medicare beneficiaries are wading through the sea of choices to enroll in Part D. But two months into the new program, the most popular choice remains not signing up.
Two months in, it is clear Medicare Part D will not meet the enrollment projections anticipated by the architects of the program when it was enacted at the end of 2003.
The pace of enrollment will actually have to accelerate over the next three months in order to reach just 50%...
The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.
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.
Clarity on payer responses to controversial vaccine recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices may be coming.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
