Pharma & Drug Safety

I&S LLC Stipulation, Agreement, and Order

The Federal Trade Commission (FTC) has entered into a Stipulation, Agreement, and Order with I&S LLC. The order addresses alleged deceptive advertising practices related to the company's subscription services. I&S LLC has agreed to specific terms to resolve these allegations.

Dutch Botanicals LLC Stipulation Agreement Order

The US Food and Drug Administration (FDA) has issued a Stipulation Agreement Order against Dutch Botanicals LLC. This order likely addresses violations related to the manufacturing or marketing of food products, requiring specific actions and potentially imposing penalties.

Galactic Meds LLC Stipulation, Agreement, and Order

The US Department of Justice has entered into a Stipulation, Agreement, and Order with Galactic Meds LLC. This agreement resolves alleged violations related to the False Claims Act, requiring Galactic Meds LLC to pay a settlement amount and implement compliance measures.

Grateful Grove LLC Stipulation Agreement Order

The Federal Trade Commission (FTC) issued a Stipulation Agreement Order against Grateful Grove LLC for deceptive advertising practices related to its "Get Sleep" product. The order prohibits the company from making unsubstantiated claims about the product's efficacy and requires specific disclosures.

FDA Draft Guidance on Medical Gases Certification Process

The FDA has issued draft guidance for industry on the certification process for designated medical gases. This guidance explains the certification process and annual reporting requirements, aiming to reduce regulatory burden for the medical gas industry. Comments are due by April 13, 2026.

FDA Guidance: Plausible Mechanism Framework for Individualized Genetic Therapies

The FDA has issued draft guidance outlining a plausible mechanism framework for developing individualized genetic therapies. This framework provides recommendations for generating substantial evidence of effectiveness and safety for these novel treatments. The comment period for this draft guidance closes on April 27, 2026.

FDA Draft Guidance Q&A on Food Traceability Records

The FDA has issued draft guidance in a Q&A format to help industry understand the requirements for additional traceability records for certain foods, as established by a final rule in 2022. Comments on this draft guidance are due by May 21, 2026.

FDA Guidance on Antimicrobial Drug Durations for Food Animals

The FDA's Center for Veterinary Medicine has issued guidance for sponsors of new animal drug applications concerning medically important antimicrobial drugs used in food-producing animals. The guidance aims to facilitate voluntary changes to define durations of use for these drugs to mitigate antimicrobial resistance.

Go Raw LLC Expands Cat Food Recall for Low Thiamine Levels

Go Raw LLC is expanding its voluntary recall of Quest Cat Food Chicken Recipe products due to low thiamine levels. The company is also stopping the sale of all Quest products until the issue is resolved. The expanded recall affects products distributed nationwide.

FDA Warning Letter to MedisourceRx

The FDA issued a warning letter to MedisourceRx on December 12, 2025, for failing to meet the conditions of section 503B of the FDCA. The inspection revealed that the outsourcing facility did not submit adverse event reports as required, violating federal drug laws.