PhRMA Seeks Regulatory Guidance On Primary Prevention Products
This article was originally published in The Pink Sheet Daily
The trade association also hopes HHS will encourage reimbursement policies that support the effective delivery of prevention products to patients, PhRMA VP-Scientific & Regulatory Affairs Loew says.
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HHS Medical Innovation Task Force report says CMS will assist FDA in postmarketing drug surveillance. The collaboration also includes parallel reviews by the two agencies to minimize delays between marketing approval and reimbursement.
Amended application includes 50 mg and 100 mg dosage forms, which are used in multiple myeloma.