News & Analysis as of

Food and Drug Administration (FDA) Pharmaceutical Industry Code of Federal Regulations (CFR)

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Morgan Lewis - As Prescribed

FDA Issues MAPP for Reviewing Color Additives and Flavors in Oral Drug Products

FDA’s Office of Pharmaceutical Quality (OPQ) issued a new Manual of Policies and Procedures (MAPP) in June explaining the agency’s internal procedures for evaluating color additives and flavors in an oral drug product...more

Lowndes

USPTO Allows Petitions for Prioritized Examination of COVID-19 Trademark Applications

Lowndes on

In an effort to help bring potentially life-saving COVID-19 treatments more quickly to market, the United States Patent and Trademark Office (USPTO) announced yesterday that it will accept petitions to advance the initial...more

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