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As the debate over how the FDA should approve follow-on biologics continues, lawmakers acknowledged more work is needed to satisfy certain patient safety and interchangeability concerns raised by the pharmaceutical industry.
The U.S. Food and Drug Administration (FDA) issued a draft guidance with recommendations on how blood product manufacturers can apply for licenses to use placental or umbilical cord blood treatments for hematological malignancies.
The FDA wants to impose new electronic reporting requirements on biological product manufacturers to assist in potential product recalls, the agency said.
A federal inquiry called to determine the adequacy of the FDA’s approval process for generic drugs might be a sign of strong support among lawmakers for legislation proposed last month that would create a clear pathway for follow-on biologics, according to industry sources.
Leading Senate Democrats believe that they are only a few votes away from having the support necessary to overcome a promised presidential veto of stem cell legislation and say that increasing public and political pressure will be enough to give them the necessary support.
The debate over federal funding of stem cell research has moved over to the Senate as two major committees will hold a joint hearing on the issue later this week.
Reintroduction of key legislation presented late last year that would establish a clear and scientifically sound pathway for the approval of follow-on biologics would save the federal government about $14 billion in Medicare costs over the next decade, according to a new report by the Pharmaceutical Care Management Association (PCMA).
Biotech company Synosis will acquire five drug candidates that target the central nervous system as part of a new partnership with Roche, Synosis announced.