Department of Health and Human Services February 9, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Medical Device Innovation Initiative; Request for Comments
The Food and Drug Administration (FDA) is announcing the availability of a document for public comment entitled ``Medical Device Innovation Initiative'' (the report). The report proposes potential actions for FDA's Center for Devices and Radiological Health (CDRH) to facilitate the development, assessment, and regulatory review of innovative medical devices.
Medical Device Innovation Initiative; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``CDRH's Medical Device Innovation Initiative Public Workshop.'' The purpose of the public meeting is to solicit feedback on select actions outlined in the Center for Devices and Radiological Health's (CDRH) document, ``Medical Device Innovation Initiative'' (report). FDA is seeking input on a number of identified challenges associated with incentivizing innovation, and the proposed solutions. In addition, the Agency requests comments on the Innovation Pathway proposed under the report.
Determination That DECASPRAY (Dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX (Dexamethasone) Topical Aerosol, 0.01%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dexamethasone topical aerosol, 0.04% and 0.01%, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for dexamethasone topical aerosol, 0.04% and 0.01%, future applicants are advised that they may not be able to obtain DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, for bioequivalence testing because the products have not been commercially available for a number of years. An ANDA applicant who is unable to obtain DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and same therapeutic effect.
Food Additives Permitted in Feed and Drinking Water of Animals; Formic Acid
The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of formic acid as an acidifying agent in swine feed. This action is in response to a food additive petition filed by Kemira Oyj of Finland.
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