Insights for Smarter Compliance and Field Operations

The cannula sets may exhibit a loose connection between the flexible tubing and the nasal cannula resulting in reduced effectiveness and decreased oxygenation.Read more

This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.Read more

Table depicting FDA's pediatric product safety communicationsRead more

On October 8, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cRead more

Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination. In immunocompromised individuals, the use of the affected product could potentially resultRead more

Roche is partnering with Chinese startup Defand Therapeutics to discover new medicines.Read more

Overview of the FDA review and approval process for generic drugsRead more

PhRMA is suing the Trump administration, smaller biotech firms are frustrated over tariffs, and more of the latest pharma news.Read more

Merck is the most exposed to risk from generic competition in the short term, but AbbVie, Johnson & Johnson, Sanofi and others will also grapple with patent losses in the years to come.Read more

Requirements and Resources for Approved Abbreviated New Drug Applications (ANDAs), including changes to an approved ANDA, postmarketing reporting, promotional materials, annual facility fees, and content of labelingRead more