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FDA Extends Comment Period on ANDA Rule
FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.
FDA announced on April 15, 2015 that it was extending the comment period for the agency’s proposed rule on abbreviated new drug applications (ANDAs) and 505(b)(2) applications to June 8, 2015, in response to requests for more comment time. The rule, published in the Federal Register on Feb. 6, 2015, was proposed “to implement portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which amended provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern the approval of 505(b)(2) applications and ANDAs. FDA also requested comment on its proposal to amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.”
Comments can be submitted online using docket number FDA-2011-N-0830.
Source: FDA.gov
FDA Approves Ebglyss for Moderate-to-Severe Atopic Dermatitis
September 16th 2024Results from the ADvocate 1, ADvocate 2, and ADhere clinical trials found that patients treated with Ebglyss 38% of patients with moderate-to-severe atopic dermatitis achieved clear or almost-clear skin after 16 weeks of treatment.
FDA Approves Subcutaneous Tecentriq Hybreza for All Adult Indications of IV Form of Tecentriq
September 13th 2024Subcutaneous Tecentriq Hybreza will provide patients and physicians increased flexibility for administration of the immunotherapy across approved indications for Tecentriq, including non–small cell lung cancer, small cell lung cancer, and hepatocellular carcinoma.
