- Image via Wikipedia
Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in August 2010 (links go directly to PDF documents).
|
Special Interest Guidances/Information |
Date Posted |
| General Considerations for Animal Studies for Cardiovascular Devices | 07/29/2010 |
|
Other Recent Guidances |
Date Posted |
| Q4B: Pharmacopoeial Texts for Use in the ICH Regions: | 09/2/2010 |
| Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment (Draft) | 08/26/2010 |
| Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use – Small Entity Compliance | 8/17/2010 |
| Label Comprehension Studies for Nonprescription Drug Products | 08/3/2010 |
| Guidance for the Non‐Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) | 08/17/2010 |
| Contact Lens Care Products Labeling | 08/15/2010 |
| Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays (Draft) | 08/06/2010 |
