FDA’s Regulatory Rock And Hard Place: How To Handle Draft Guidances
Republicans on the Senate HELP Committee say they are concerned that FDA is using draft guidance documents to set substantive policy, which they argue puts companies in a difficult position.
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Commissioner Hamburg describes a Catch-22, warning that pressure to finalize guidances faster without more resources could result in fewer discretionary guidances, disappointing stakeholders.
Pfizer Says FDA Draft Guidance Is Just Fine; Congress Should Be Patient
In an unusual move, industry rep indicates comfort with draft guidance implementing biosimilar pathway.
Accelerated Approval Labeling Caveat Draws Industry Ire
FDA draft proposal could lead providers, patients and insurers to mistakenly believe a drug cleared under the expedited pathway does not meet the same standards as other drugs, PhRMA and BIO say.