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Last updated 3 days ago
Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), Due To The Potential Presence of Visible Particulates
3 days ago
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol...
Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination
3 days ago
Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot...
FDASIA Section 705 Annual Reports
3 days ago
Annual Reports published by requirement of FDASIA Section 705
Drug Compliance Programs
3 days ago
FDA compliance programs provide guidance and instructions to FDA staff for obtaining...
FDA is requiring opioid pain medicine manufacturers to update prescribing information regarding long-term use
3 days ago
FDA is requiring safety labeling changes for opioid pain medicines to further...
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs
4 days ago
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs
Innovative Science and Technology Approaches for New Drugs (ISTAND) Program Submission Process
4 days ago
The 21st Century Cures Act formally established a multi-step process for Drug...
CDER Conversation: Novel Excipient Review Pilot Program
4 days ago
FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs...
Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA
4 days ago
This Table provides the current number of active CDER Drug Development Tool...
Digital Health Technologies (DHTs) for Drug Development
4 days ago
Digital Health Technologies (DHTs) for Drug Development
Innovative Science and Technology Approaches for New Drugs (ISTAND) Program
4 days ago
The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program...
FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program
4 days ago
ISTAND supports innovative, science-driven approaches that improve drug development and regulatory decision-making...