FDA Center for Drug Evaluation and Research - What's New 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.FDA Helps to Deliver Meaningful Advances for Rare Disease Patients
We remain committed to supporting rare disease research, engaging patients and caregivers to understand their unique perspectives, and enhancing our review processes to advance medical products for rare disease patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Natural History Studies and Registries in the Development of Rare Disease Treatments - 05/13/2024
Natural History Studies and Registries in the Development of Rare Disease Treatments (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Sociodemographic Characteristics of Adverse Event Reporting
Researchers in CDER ’s Office of Surveillance and Epidemiology and others examined the sociodemographic characteristics of individuals who submit FAERS reports (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Drug Development Considerations for Empiric Antibacterial Therapy in Febrile Neutropenic Patients - 04/23/2024
The purpose of the public workshop is to discuss clinical trial design and other considerations related to the development of antibacterial drug products for treatment of febrile neutropenia (FN). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 28, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Remarks by Commissioner Robert Califf to the AIRIS Workshop - 02/26/2024
Speech by Dr. Robert M. Califf, MD
Commissioner of Food and Drugs
Airis Workshop
Feb. 26, 2004
Seoul, South Korea (by video) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 28, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Roundup: February 27, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Safety Outcomes When “Switching” Between Biosimilars and Reference Products
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
EzriCare LLC - 658390 - 02/13/2024
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Delsam Pharma LLC - 657340 - 02/13/2024
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Amman Pharmaceutical Industries - 668867 - 02/14/2024
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
LightEyez Limited - 665450 - 02/15/2024
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Patient Medication Information (PMI)
FDA is proposing to amend its human prescription drug labeling regulations to require a new type of Medication Guide —"Patient Medication Information”—for prescription drug products used, dispensed, or administered on an outpatient basis (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Sichuan Deebio Pharmaceutical Co. Ltd. - 669808 - 02/05/2024
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment Due to Potential Lack of Sterility
Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food an (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
