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 Enhances Global Patient and Regulatory Collaborations in Oncology
In recognition of World Cancer Day 2024, the FDA and European Medicines Agency will collaborate to spotlight innovative cancer treatment advances for patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 30, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
S & J International Enterprises Public Company Limited - 668482 - 01/26/2024
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 - January 30, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Sambrosa Care Inc. - 673321 - 01/24/2024
Finished Pharmaceuticals/Unapproved New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 30, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Mei Lan Thailand Co., Ltd. - 672783 - 01/22/2024
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Refused Inspection (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 30, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
October 5, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 10/05/2023
October 5, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune ’s Fix
Neptune Resources, LLC is voluntarily recalling All lots of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets to the consumer level. Neptune Resources LLC's distribution channels have not reported any adverse events from the use of its products. The products are be (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA revises letter of authorization for the emergency use authorization for Paxlovid
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 29, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process
By clarifying FDA ’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Drug Competition Action Plan | Closing loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition Congress intended
FDA aims to reduce the so-called “gaming” that frustrates and delays generic drug approvals and extends brand monopolies beyond what Congress intended with the Hatch-Waxman Amendments of 1984. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Drug Competition Action Plan | Maximizing scientific and regulatory clarity with respect to complex generic drugs
Complex generic products are typically harder to develop, which means that many complex products face less competition than other products, and therefore can be more expensive and less accessible to the patients who need them. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Compounding Quality Center of Excellence | Cross-Sector Stakeholder Group
Compounding Quality Center of Excellence Cross-Sector Stakeholder Group (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Outsourcing Facilities Annual Study
Compounding Outsourcing Facilities Annual Study (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Compounding Quality Center of Excellence | Annual Conference
Compounding Quality Center of Excellence Virtual Conference (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Compounding Quality Center of Excellence | Recorded Webinars
The FDA Compounding Quality Center of Excellence offers free recorded webinars to provide information about current good manufacturing practice standards and the agency ’s inspectional processes. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
