Department of Health and Human Services February 13, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability
The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Bioequivalence Recommendations for Rifaximin,'' one for the 200- milligram (mg) strength (rifaximin-200) and one for the 550-mg strength (rifaximin-550). The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for rifaximin tablets.
Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray/Sublingual Products and Metered Aerosol/Sublingual Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Bioequivalence Recommendations for Nitroglycerin,'' one for nitroglycerin metered spray/sublingual products and one for nitroglycerin metered aerosol/sublingual products. The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for these products. The draft guidances are revised versions of previously published draft guidances on the subject.
Determination That WILPO (phentermine hydrochloride) Tablets, 8 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that WILPO (phentermine hydrochloride) Tablets, 8 Milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve Abbreviated New Drug Applications (ANDAs) for phentermine hydrochloride tablets, 8 mg, if all other legal and regulatory requirements are met.
Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin for Quality; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.'' This draft guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, and others to the potential risk of crude heparin contamination.
Determination That KAPVAY (Clonidine Hydrochloride) Extended-Release Tablets, 0.2 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that KAPVAY (clonidine hydrochloride) Extended-Release Tablets, 0.2 milligram (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for clonidine hydrochloride extended- release tablets, 0.2 mg, if all other requirements are met.
Determination That JENLOGA (Clonidine Hydrochloride) Extended-Release Tablets, 0.1 Milligram and 0.2 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that JENLOGA (clonidine hydrochloride) Extended-Release Tablets, 0.1 milligram (mg) and 0.2 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for clonidine hydrochloride extended-release tablets, 0.1 mg and 0.2 mg, if all other requirements are met.
Antiparasitic Drug Use and Resistance in Ruminants and Equines; Public Meeting; Request for Comments
Blood Products Advisory Committee; Cancellation
The meeting of the Blood Products Advisory Committee scheduled for February 29, 2012 is cancelled. This meeting was announced in the Federal Register of January 30, 2012 (77 FR 4567). FDA intends to convene at a future date a public scientific workshop to discuss the evaluation of possible new plasma products manufactured following storage at room temperature for up to 24 hours.
Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives and Consumer Representatives on Public Advisory Committees or Panels
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through February 2013.
Regulatory Agenda
The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department with a view to offering summarized information about forthcoming regulatory actions for public review.
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