FDA Roundup: October 11, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Temporary Policies for Compounding Certain Parenteral Drug Products
Temporary Policies for Compounding Certain Parenteral Drug Products
FDA Clinical Investigator Training Course (CITC) 2024 - 12/10/2024
FDA Clinical Investigator Training Course (CITC) 2024
Good Clinical Practice
The following resources are provided to help investigators, sponsors, and contract research organizations who conduct clinical studies on investigational new drugs comply with U.S. law and regulations covering good clinical practice (GCP).
Drug Trials Snapshots: XDEMVY
XDEMVY is an ectoparasiticide that treats Demodex blepharitis. Blepharitis is a type of eyelid infection.
FDA Approves New Treatment for Hemophilia A or B
The FDA approved a new treatment for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A or B, both without inhibitors.
Infusion Pump Recall: Zyno Medical Removes Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients
Zyno Medical Z-800 infusion pumps allow for infusions through the blood vessels but a software defect may allow air bubbles to enter the patient.
October 11, 2024
The FDA approved a new treatment for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A or B, both without inhibitors.
Empower Pharmacy. Houston, TX. 483 issued 8/28/2024
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 8/28/2024 Short Title (70 char) Empower Pharmacy. Houston, TX. 483 issued 8/28/2024 FEI Number 3011887629 Firm
Barclay, Luke, and Pillai Specialty Pharmacy PLLC, dba Meta Pharmacy Services. Las Vegas, NV. WLCO issued 3/15/2024
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 3/15/2024 Short Title (70 char) Barclay, Luke, and Pillai Specialty Pharmacy PLLC. Las Vegas, NV. WLCO issued 3
Drug Trials Snapshots: TZIELD
TZIELD is a drug that is used to delay the onset of type 1 diabetes in children and adults who are at high risk for type 1 diabetes.
FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer
On October 10, 2024, the Food and Drug Administration approved inavolisib (Itovebi, Genentech, Inc.) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone recep
La FDA advierte a los consumidores de que no compren ni utilicen productos Umary y Amazy, ya que pueden ser perjudiciales para su salud
La FDA advierte a los consumidores de que no compren ni utilicen productos Umary y Amazy, ya que pueden ser perjudiciales para su salud
Bioterrorism and Drug Preparedness
FDA is working with other federal agencies to make sure adequate supplies of medicine and vaccines are available to the American public.
Federal Court Enters Consent Decree Against Rizo Lopez Foods Inc. Following Multistate Outbreak of Listeriosis Linked to Queso Fresco and Cotija Cheese Products
U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction against Rizo Lopez Foods Inc. prohibiting the company from manufacturing and selling certain
Hurricane Helene: Baxter's manufacturing recovery in North Carolina
Information and updates on CDER-regulated drug and biologic products
Updates on 2024 Hurricane Season
CDER updates on recovery efforts during the 2024 Hurricane season, including information on Baxter's manufacturing recovery in North Carolina and updates to CDER-regulated products,
October 8, 2024
U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction against Rizo Lopez Foods Inc. prohibiting the company from manufacturing and selling certain
Former Nurse Pleads Guilty in Connection with Diverting Fentanyl from ICU Patient
FDA-OCI, District of New Hampshire, Concord, Northfield, New Hampshire, Lisa Richardson, Concord Hospital
Mexicanrxpharm.com - 693163 - 09/30/2024
Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
Louisiana State University Health Science Center IRB - 686088 - 09/27/2024
Institutional Review Board (IRB)
Nanchang Anobri Pharmaceutical Co., Ltd. - 11/21/2023
Nanchang Anobri Pharmaceutical Co., Ltd. - 11/21/2023. Country: China. Record Type: 483
Aqualex Co., Ltd. - 10/20/2023
Aqualex Co., Ltd. - 10/20/2023. Country: Korea (Republic of). Record Type: 483