Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access
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Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of a representative population in their clinical trials.Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act
This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug.Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication
Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolicBlendHouse LLC. Reading, PA. 483 issued 02/17/2023
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 02/17/2023
Short Title (70 char) BlendHouse LLC. Reading, PA. 483 issued 02/17/2023
FEI Number 3015728839
Firm Name BlendHouse LLC
Record Type 483
State PA
Establishment Type ManufacturerLiquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate due to Contamination
Nipro recalls bicarbonate dialysate concentrate due to contamination. Learn about potential serious injuries, fatality risks and essential steps for healthcare providers and patients for this Class I recall.Albertsons Companies Stores in Arkansas, Louisiana, Oklahoma and Texas Voluntarily Expands Recall to Select Items Containing Tuna Salad from Reser’s Fine Foods Due to an Ingredient Recall Linked to Possible Listeria monocytogenes Contamination
Albertsons, Randalls and Tom Thumb stores in Arkansas, Louisiana, Oklahoma and Texas are voluntarily recalling select items containing tuna salad supplied by Reser’s Fine Foods. This action follows a recall initiated by Reser’s Fine Food due to possible contamination with Listeria monocytogenes in b