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The FDA is readying several new drug safety initiatives for 2006 with an eye toward more doctor self-regulation, better data collection and public outreach efforts, according to a top agency official.
The FDA’s Office of Generic Drugs (OGD) has launched its Dissolution Methods Database aimed at improving the quality and turnaround time of abbreviated new drug applications (ANDAs).
The FDA has issued draft guidance and a proposed rule advising manufacturers how to control risks associated with tinnitus masker
devices (TMDs), which treat ringing in the ears.
Analysts and democratic staffers are pointing to U.S. Pharmacopeia’s (USP) recent decision to revise its model formulary guidelines as an opportunity to ensure that beneficiaries have access to the broadest array of certain essential drugs under the new prescription drug plan.
Analysts and democratic staffers are pointing to U.S. Pharmacopeia’s (USP) recent decision to revise its model formulary guidelines as an opportunity to ensure that beneficiaries have access to the broadest array of certain essential drugs under the new prescription drug plan.
Drugmakers should use electronic methods to distribute important product information such as recalls and drug safety bulletins, according to a new FDA draft guidance that explains procedures for doing so based on regulations for compliant paper circulation of those announcements.
One potential problem with making follow-on biologics is that there isn’t enough data to show how changes in manufacturing processes might affect a product’s safety and efficacy, one expert said during a regulatory affairs conference in Baltimore.
Sharps injury prevention features on medical devices should be easily discernible to the user, and, once activated, should remain protective through disposal of the device, according to a new guidance that stresses design controls as a way to prevent needle-stick injuries.