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Aevi Genomic Medicine commented that “the proposed remedy is likely to impede and delay development of important new medicines for children.” Read More
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 be provided in authorization applications for starting materials. Read More
A former Horizon Pharma senior director sued the drugmaker, claiming she was fired for raising concerns about off-label drug promotion at a previous employer. Read More
Compounds in kratom “are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death,” said FDA Commissioner Scott Gottlieb. Read More
The agency removed a requirement that two independent evaluation reports be provided at the time of application from acceptable countries where the product is already approved. Read More
The FDA issued final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling. Read More
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 for drugs like Vicodin and Percocet usually intended for short-term use. Read More
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Product and fast-track designations for antibiotics must specifically request both designations, according to a new draft guidance from the FDA. Read More