Tag food and drug administration

Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical Amendment

Nov14

Final rule; technical amendments.CFR Part: “21 CFR Parts 5, 10, 14, 20, 21, 314, 350, 516, and 814″Citation: “79 FR 68114″Document Number: “Docket No. FDA-2011-N-0318″Page Number: “68114”“Rules and Regulations”SUMMARY: The Food and Drug Administration (FDA) is amending the Agency’s regulations to change the Division of Freedom of Information’s (FOI’s) name, and remove the address, telephone […]

FDA Issues Technical Amendments to Change Division of Freedom of Information’s Name, Telephone and Fax Number

Nov14

Targeted News ServiceWASHINGTON, Nov. 14 The U.S. Food & Drug Administration published the following rule in the Federal Register:Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical AmendmentA Rule by the Food and Drug Administration on 11/14/2014Publication Date: Friday, November 14, 2014Agencies: Department of Health […]

FDA approves Roche’s Avastin for ovarian cancer

Nov14

NEW YORK (AP) Swiss drugmaker Roche said Friday that the Food and Drug Administration approved its drug Avastin as a treatment for ovarian cancer. Roche said the FDA approved Avastin in combination with chemotherapy as a treatment for recurrent cases of cancer that are resistant to platinum-based chemotherapy. Avastin is used to treat different types […]

FDA lodges FIRs against 5 pharmacy suppliers [DNA : Sunday]

Apr20

In a major crackdown against illegal export of drugs, the Food and Drug Administration (FDA) has seized drugs worth Rs2.47 crore from 28 locations in three months. It has registered FIRs against nine people, including five suppliers. The exported drugs include addictive anti-depressants, anti-hypertensives and sex boosters."In the crackdown since January, the FDA has been […]

Chongqing Lummy Temodar Bulk Drug Nodded for Sale in US

Dec31

CHONGQING, December 31, SinoCast Chongqing Lummy Pharmaceutical Co., Ltd. (SZSE: 300006) revealed a notice received from the Food and Drug Administration (FDA), approving the Chinese drug maker to sell off Temodar bulk drug in US, which will widen potential market destination, optimize product portfolios and further promote its products abroad.

Meeting Notice of Cellular, Tissue and Gene Therapies Advisory Committee Posted in Federal Register

Dec31

WASHINGTON, Dec. 31 The U.S. Department of Health and Human Services published the following notice in the Federal Register from the Food and Drug Administration:Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of MeetingA Notice by the Food and Drug Administration on 12/31/2013Publication Date: Tuesday, December 31, 2013Agencies:Department of Health and Human ServicesFood and Drug […]

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 58311)

Dec30

TIME: 8 a.m.EVENT: Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 58311) holds a workshop titled “Complex Issues in Developing Drug and Biological Products for Rare Diseases,” to discuss complex issues in clinical trials for developing drug and biological products for rare diseases, and to discuss ways to encourage and […]

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 76307)

Dec30

TIME: 8 a.m.EVENT: Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 76307) holds a meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss new drug application (NDA) 204886, vorapaxar sulfate, proposed trade name ZONTIVITY, 2.5 milligram tablets, submitted by Merck Sharp & Dohme Corp., Inc., for the proposed […]

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 76308)

Dec30

TIME: 8 a.m.EVENT: Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 76308) holds a meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss supplemental new drug application (sNDA) 202439/S-002, rivaroxaban, trade name XARELTO 2.5 milligram tablets, submitted by Janssen Pharmaceuticals, Inc., for the proposed indication to reduce the […]

Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 77688)

Dec30

TIME: 8 a.m.EVENT: Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 77688) holds a meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee to review the application for the Visian Toric Implantable Collamer Lens (TICL) sponsored by STAAR Surgical Company, for the correction of myopic astigmatism in […]