Is FDA Picking Up the Regulatory Pace?

It seems early in the oversight of the new FDA Commissioner and Deputy Commissioner to the agency turning a corner, or maybe not.

There have been two indications of possible increased enforcement that have emerged in the past few days that lead one to at least wonder if the FDA is getting more serious about enforcement. 

First, as mentioned in the Weekly Roundup on Friday, Caraco Pharmaceuticals experienced a seizure by U.S. Marshalls of product.  This occurred after a long period of regulatory interaction.  

Second, in the same week, the FDA issued a Notice of Intent to Revokethe biologics manufacturing license to Immucor regarding a facility in Georgia, also following regulatory interactions. 

Regulatory actions take time to organize and move in the bureacratic machinery and it could be that these efforts were in the works for a while and it is perhaps too early to determine if the FDA is picking up the regulatory pace.  But if we start seeing Consent Decrees, then we may be in fact seeing a sea change in enforcement.

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