FDA recently released a new draft guidance, “Innovative Approaches for Nonprescription Drug Products,” that described two “innovative approaches” that sponsors of new drug applications may wish to consider to demonstrate the...more
On June 20, 2018, the Food and Drug Administration (“FDA”) released draft guidance for companies required to comply with the FDA’s final rule, “Mitigation Strategies to Protect Food Against Intentional Adulteration” (“IA...more
On June 20, 2018, the FDA released draft guidance regarding the FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration Rule (IA Rule). This is the first of three installments of guidance the FDA plans...more
On Friday, the FDA announced the availability of a draft guidance describing its current thinking on how to determine whether a business is a “qualified facility” that is subject to modified requirements under its previously...more
On Friday, October 30, 2015, FDA issued a Federal Register notice announcing a partial stay of the agency’s controversial Final IND Guidance entitled, “Investigational New Drug Applications—Determining Whether Human Research...more
The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA). The draft guidance...more