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The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Evolus for exaggerating efficacy claims for its drug Jeuveau (prabotulinumtoxinA-xvfs) and for “blurring the lines” between prescription products and consumer cosmetics on Instagram.

The US Food and Drug Administration (FDA) recently issued warning letters to ophthalmic product maker Bausch and Lomb and an Indian active pharmaceutical ingredient (API) maker for violations of good manufacturing practice (GMP). Both companies were cited for having lax contamination controls.

The US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Alar Pharmaceuticals, accusing the company of making misleading claims regarding the safety and effectiveness of ALA-3000 (ketamine pamoate), its investigational new drug for treatment-resistant depression (TRD).

The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement.

The US Food and Drug Administration (FDA) recently issued two warning letters to a sterile drug manufacturer and an over-the-counter (OTC) drug maker in the US for multiple violations of good manufacturing practices (GMPs). These violations included inadequate contamination controls, failure to investigate batch issues, and insufficient testing of components.

The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions about the necessity of inspections and clarifies the agency’s use of alternative methods instead of relying solely on onsite inspections.

The US Food and Drug Administration (FDA) has issued warning letters to several drugmakers for violations of current good manufacturing practices (CGMP). The agency also issued a warning letter to a Chinese drugmaker for marketing drugs in the US without providing regulators with the critical records needed to ensure compliance.

PHILADELPHIA – Adhering to quality by design (QbD) principles and employing risk-based monitoring strategies should reduce the likelihood of clinical investigators or sponsors receiving a Form 483 following a bioresearch monitoring inspection.

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and purchasing, and complaint handling and feedback.