Archives
Medical Device Updates
- Voluntary Malfunction Summary Reporting Program finalized Aug 16, 2018
- Philips’ Ultrasound Systems Cleared by FDA
- FDA Guidance: Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use Guidance for Industry
- Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Issued on November 5, 2018
Combination Products Updates
- FDA Extends Malfunction Summary Reporting Program to Combo Products
- FDA Guidance: Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications
- FDA Guidance Document: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
- FDA Guidance Document: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs
Regulatory Actions
- Warning Letter > Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration
- Warning Letter > Apotex plant in India hit with third warning letter in 4 years.
- Recall > Pfizer recalls 1 lot of Children’s Advil due to overdosing concerns
- Warning Letter > PharmaMedics Aug 16, 2018-RE: Notice of Unlawful Sale of approved and Misbranded Opioids to United States Consumers Over the Internet
- Recall > Compass Health Recalls Full Face Mask Cushion Devices
- Warning Letter > Zimmer Biomet, Inc. 8/24/18
- Warning Letter > Medtronic Puerto Rico Operations Co. 8/23/18
- Warning Letter > ITG-Medev Inc 9/7/18
- Warning Letter > Pharmaceutical Laboratories and Consultants, Inc. 8/29/18
- Warning Letter > Becton Dickinson Medical Systems 9/14/18
- Warning Letter > Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing 11/26/18
- Recall > Beckman Coulter Life Sciences Recalls FC 500 and the EPICS XL Series Flow Cytometers Due to Risk of Inaccurate Results 11/20/18
- Recall > Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex 11/20/18
- Warning Letter > Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect 11/27/18
- Warning Letter > Zimmer Biomet, Inc. Recalls Spinal Fusion and Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness 11/27/18