GDUFA Science and Research Outcomes for Fiscal Year 2023
FDA has posted its report on the extent to which GDUFA-funded science and research projects were supported in FY23.
Proteinuria and GFR as Clinical Trial Endpoints in Focal Segmental Glomerulosclerosis: A Scientific Workshop - 10/07/2024
The goal of this scientific workshop is to advance the use of proteinuria and eGFR-based endpoints as surrogate endpoints for accelerated and traditional approval of new treatments for FSGS.
About Orphan Products Clinical Trial Grants
A general overview of the orphan products clinical trials grants program
FDA approves selpercatinib for medullary thyroid cancer with a RET mutation
On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic medu
Drug Trials Snapshots: RYTELO
RYTELO is a prescription medicine used to treat a condition called low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with anemia.
Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice - 03/05/2024
On March 5th, 2024, FDA is conducting a public workshop to discuss aspects of complex adaptive, Bayesian, and other novel clinical trial designs. This meeting is being conducted to meet the performanc
Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement
paraPAC Plus P300 and P310 Ventilators are gas-powered emergency and transport portable ventilators. The tidal volume knob may move out of the set position.
FDA approves imaging drug for evaluation of myocardial ischemia and infarction
FDA approves imaging drug for evaluation of myocardial ischemia and infarction
FDA approves selpercatinib for RET fusion-positive medullary thyroid cancer
On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic medu
27 Individuals Indicted for Buying and Selling Wholesale Quantities of Misbranded and Diverted Prescription Drugs Resold to the Public Through Retail Pharmacies in Puerto Rico
FDA-OCI, District of Puerto Rico, San Juan, Bayamón, Aibonito, Canóvanas, Luquillo, Puerto Rico, HHS OIG, Farmacia Monte Verde, Farmacia Santa Olaya, Farmacia Unity, Farmacia San Antonio, Farmacia Brisas del Mar,
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act
FDA Roundup: September 27, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
September 27, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targ
FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns
FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns
Amazy contains hidden drug ingredients
The U.S. Food and Drug Administration is advising consumers not to purchase or use Amazy, a product promoted and sold for pain on various websites, including Amazon.com, and possibly in some retail stores.
Ácido Hialurónico contains hidden drug ingredient
The U.S. Food and Drug Administration is advising consumers not to purchase or use Ácido Hialurónico (or Acid Hyaluronic), a product promoted and sold for pain on various websites, including ebay, and possibly in some retail stores.
September 26, 2024
FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targ
FDA notification regarding unapproved drugs included in kits
On September 20, 2024, FDA requested Azurity Pharmaceuticals Inc. stop distributing unapproved drugs marketed as “Unit-of-Use Prescription Compounding Kits.
Fagron Compounding Services, LLC dba Fagron Sterile Services. Wichita, KS. 483 issued 06/28/2024
Record Date 06/28/2024 Short Title (70 char) Fagron Compounding Services, LLC dba Fagron Sterile Services. Wichita, KS. 483 issued 06/28/2024 FEI Number 3012104093 Firm Name Fagron Compounding Service
ProRx LLC. Exton, PA. 483 issued 8/2/2024
Task Description Request Please post to the ORA Electronic Reading Room Record Date 8/2/2024 Short Title (70 char) ProRx LLC. Exton, PA. 483 issued 8/2/2024 FEI Number 3022250654 Firm Name ProRx LLC R
FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy
On September 25, 2024, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer.