FDA streamlines CGMP compliance for combination products *

USA - January 24 2013
On January 22, 2013, the U.S. Food and Drug Administration (FDA) published its final rule implementing current good manufacturing practice (CGMP)…

Co-authors: Donald E. Segal, Guillermo E. Cuevas.

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FDA acceptance policies on PMA and 510(k) submissions *

USA - January 14 2013
On December 31, 2012, FDA issued two guidance documents detailing the agency's approach to reviewing the completeness of medical device applications…

Co-authors: Donald E. Segal, Guillermo E. Cuevas.

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United States v. Caronia – watershed decision on off-label promotion? *

USA - December 11 2012
The regulatory landscape regarding off-label drug promotion may be changing in light of the Second Circuit’s recent decision in United States v. Caronia.

Co-authors: Guillermo E. Cuevas, Marc J. Scheineson.

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On the horizon – what to expect from FDA in 2013 *

USA - November 15 2012
With the reelection of President Obama, the U.S. Food and Drug Administration (FDA) is likely to continue its current high level of regulatory oversight and enforcement.

Co-authors: Guillermo E. Cuevas.

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Ripe for congressional reform *

USA - November 15 2012
In response to the NECC fungal meningitis outbreak, Representative Edward Markey (D-MA) introduced new legislation to expand FDA authority over prescription drug compounders.

Co-authors: Guillermo E. Cuevas.

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