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Upcoming FDA guidance is necessary to accelerate approvals of combination products because of lingering uncertainties about whether manufacturers must meet drug or device requirements, industry officials and consultants say.
Industry officials and consultants say that upcoming FDA guidance is necessary to accelerate approvals of combination products because of lingering uncertainties about whether manufacturers must meet drug or device requirements.
The FDA’s much-touted Critical Path Initiative, which is supposed to speed the introduction of new products to market, is being held back by limited agency funding, as well as several ongoing controversies, according to agency and industry officials.
The FDA has developed "validation and conformance rules" to help drugmakers properly submit structured product labeling (SPL) documents to its new electronic labeling information processing system (ELIPS).
The FDA has released a draft guidance that encourages industry to electronically distribute important product information, such as that included in recalls and drug safety announcements, and it explains procedures for doing so based on regulations governing the paper circulation of such information.
The FDA has issued a proposed rule that would streamline cGMPs for the manufacture of positron emission tomography (PET) drugs, making it easier for drug producers to comply with federal quality requirements.