The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should…
More U.S. states have aligned their oversight of drug compounding with federal standards in the last two years even though some states dropped inspections, according to an analysis by the…
The EMA’s Committee for Medicinal Products for Human Use adopted a revised guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease, focusing on the design and…
PhRMA and BIO called on U.S. trade officials to add the European Union to a list of countries that do not adequately protect intellectual property following the release of two…
FDA guidance that proposes to close what the agency sees as a “loophole” allowing drug developers to bypass pediatric study requirements would negatively impact child drug development if it becomes…
The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Source: International Pharmaceutical Regulatory Monitor
The FDA updated its guidance to institutional review boards and clinical investigators, detailing its views on reimbursements for lodging and travel for clinical trial participants. Source: International Pharmaceutical Regulatory Monitor
Drug products seeking an FDA designation as a medical countermeasure — defined as products used to diagnose, prevent or treat conditions associated with chemical, biological, radiological and nuclear threats —…
The FDA proposed a new tactic in its fight against the opioid epidemic — blister packs of smaller quantities of opioid drugs that could give providers better prescription options, especially…
Drug sponsors seeking Qualified Infectious Disease Product and fast-track designations for antibiotics must specifically request both designations, according to a new draft guidance from the FDA. Source: International Pharmaceutical Regulatory…