Quality Systems

The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.

FDA issued a warning letter to College Pharmacy for multiple violations.

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.

FDA issued a warning letter to the company for quality control violations.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.

The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.

Arbor Pharmaceuticals is voluntarily recalling Cetylev (acetylcysteine) effervescent tablets due to inadequate seal of the blister pack.

The Chinese facility was cited for data integrity violations.

The Group is focusing on standardizing data exchanges between the enterprise serialization management function and product packaging lines.

Nine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.

Flawed testing and analysis and a failure to analyze the root cause of customer complaints were among the top problems noted in FDA's letter to the Florida-based transdermal drug manufacturer.

The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.

The company received breakthrough therapy designation for esketamine, a treatment for major depressive disorder with imminent risk for suicide.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

NICE recommends secukinumab for the treatment of patients with ankylosing spondylitis.

The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.

FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.

The company is voluntarily recalling one lot of product due to particulate matter.

The company is voluntarily recalling liquid products due to possible Burkholderia cepacia contamination.

The three-year report emphasizes the roll of collaboration in drug safety.

The report addressed how the agency might support medicine development for patients’ unmet medical needs.

The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.

A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.

The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.