-
Clovis Oncology, Inc., AstraZeneca Pharmaceuticals LP, and GlaxoSmithKline LLC; Withdrawal of Approval of the Indications for Advanced Ovarian Cancer for Poly (ADP-Ribose) Polymerase Inhibitors RUBRACA (Rucaparib) Tablets, LYNPARZA (Olaparib) Tablets, and ZEJULA (Niraparib) Capsules
The Food and Drug Administration (FDA or Agency) is announcing that it is withdrawing approval of the indications for the treatment of adult patients with advanced ovarian cancer for poly (ADP-ribose) polymerase (PARP) inhibitors under three new drug applications (NDAs) from multiple applicants. The applicants Read more
-
Determination That ISUPREL (Isoproterenol Hydrochloride) Injection, 0.2 Milligrams per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that ISUPREL (isoproterenol hydrochloride) injection, 0.2 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 ISUPREL Read more
-
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Use of Minimal Residual Disease as an Endpoint in Multiple Myeloma Clinical Trials
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the Read more
-
Agency Information Collection Activities; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning Read more
-
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled “Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle” has been approved by the Office of Management and Budget Read more
-
ACLA President to Testify on Regulation of Diagnostic Tests
Washington, D.C. – American Clinical Laboratory Association (ACLA) President Susan Van Meter will testify before the House Energy and Commerce Committee’s Subcommittee on Health for a hearing … Read More The post ACLA President to Testify on Regulation of Diagnostic Tests appeared first on American Clinical Laboratory Read more