FDA Guidance: Regulations in Disguise? - Bloomberg Law

William Garvin, Shareholder in the firm's FDA & Biotechnology section, comments on the FDA's over-reliance on guidance documents in Bloomberg Law's article "FDA Guidance: Regulations in Disguise?"

William Garvin, a Washington-based life sciences attorney at Buchanan Ingersoll & Rooney PC, told Bloomberg Law Dec. 11 that the FDA might be pushing guidance-based requirements too far.

"It gives the agency flexibility to change their position if the situation changes," he said. "So in general, the use of guidances is an important tool for the FDA that can be subject to abuse."