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GPhA’s Goals For 2013: Smooth GDUFA Implementation, Workable Biosimilar Pathway

 
• By Sue Sutter

The generic drug trade association’s cross-cutting priorities are the result of an extensive strategic planning process, CEO Ralph Neas says; the group is planning outreach to Congress and the executive branch to highlight the role generic drugs can play in helping to address the nation’s fiscal problems.

The Generic Pharmaceutical Association is heading into its annual meeting in Orlando, Fla. with a new strategic plan focused on a host of cross-cutting regulatory, policy, legislative and legal issues, as well as goals for growing its organizational revenues, membership ranks and internal staff in the coming year.

The group’s 2012 annual report, which will be released in connection with the Feb. 20-22 meeting, reflects a new level...

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More from United States

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 
• By Sarah Karlin-Smith

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

US Budget Bill Eases IRA Price Controls But Coverage Losses Will Impact Pharma

 
• By Cathy Kelly

The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.

How Could MFN Pricing Impact Commercial Market?

 
• By Angela Maas

Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.

More from North America

How Could MFN Pricing Impact Commercial Market?

 
• By Angela Maas

Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.

COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
• By Sue Sutter

New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.

Medicare’s Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

 
• By Cathy Kelly

The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.