In recognition of the infant formula crisis facing the United States supply chain, the Food and Drug Administration (“FDA”) issued guidance on May 16, 2022 providing for enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain statutory and regulatory requirements. The guidance remains in effect until November 14, … Continue Reading
At the time of this writing, two companies, Pfizer Inc. and Moderna, Inc., have announced promising early results from Phase 3 of their COVID-19 vaccine trials. Additional promising results are hoped for from Johnson & Johnson, and AstraZeneca soon, and perhaps from others later. This is good news. Developing a vaccine is one thing, however. Distributing it is another. Indeed, managing … Continue Reading
