| Synopsis of Q1 Pacific Region FDA Regulatory Update Available from Expandable |
| The FDA Pacific Regional Office holds quarterly regulatory update meetings with interested parties to connect the FDA with life sciences manufacturers and create an open avenue of communication to provide insight on the direction of regulatory activities. |
| After attending the Q1 meeting on March 9, 2011, Expandable’s Dennis Payton created a brief that summarizes the points made by FDA representatives at the meeting so that those not able to attend can gain the benefit of the information presented. |
| FDA-regulated customers of Expandable may be interested in reading the summary of the meeting where FDA representatives touched on a variety of informative topics: |
- Spectrum of FDA responsibility
- Scope of FDA Pacific Regional Office
- Breakdown of specific numbers of regulated establishments in the Pacific region
- Trends in Inspections, Observations and Warning Letters
- Top drivers of issues leading to Warning Letters
- Top Ten QS 483 Observations
- Controls for Medical Device Software
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View the summary of the Q1 FDA Regional Office Regulatory Update. |
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