The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that DUVYZAT (givinostat), approved on March 21, 2024, manufactured by Italfarmaco S.p.A., meets the criteria for a priority review voucher.
Determination That VISTARIL (Hydroxyzine Pamoate) Oral Suspension, 25 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 mg/5 mL, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Determination That KEMSTRO (Baclofen) Orally Disintegrating Tablets, 10 Milligrams and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that KEMSTRO (baclofen) orally disintegrating tablets, 10 milligrams (mg) and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 baclofen orally disintegrating tablets, 10 mg and 20 mg, if all other legal and regulatory requirements are met.
1380 Institutes Certified to Conduct Clinical Trials in China
“Quality Management Practice Specification for Clinical Trials of Medical Devices (so called China GCP)”, implemented from March 2022, specifies that “Clinical trial sites must be on the NMPA filed institutions […]
The post 1380 Institutes Certified to Conduct Clinical Trials in China appeared first on China Med Device.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Requirements: Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; DUVYZAT (givinostat)
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that DUVYZAT (givinostat), approved on March 21, 2024, manufactured by Italfarmaco S.p.A., meets the criteria for a priority review voucher.
Determination That VISTARIL (Hydroxyzine Pamoate) Oral Suspension, 25 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 mg/5 mL, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Determination That KEMSTRO (Baclofen) Orally Disintegrating Tablets, 10 Milligrams and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that KEMSTRO (baclofen) orally disintegrating tablets, 10 milligrams (mg) and 20 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 baclofen orally disintegrating tablets, 10 mg and 20 mg, if all other legal and regulatory requirements are met.