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August 29, 2016
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.
August 17, 2016
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.
August 16, 2016
The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.
August 11, 2016
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.
August 09, 2016
The three-year report emphasizes the roll of collaboration in drug safety.
August 04, 2016
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.