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The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended thirteen products, including its first biosimilar for Genentech’s blockbuster drug Herceptin. Read More
CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
Following the destruction by Hurricane Maria in Puerto Rico, FDA Commissioner Scott Gottlieb said one of the agency’s main goals in the recovery effort is to bring the island’s medical product manufacturing plants back into operation. Read More
The European Medicines Agency updated two guidelines on clinical trials for cardiovascular treatments in acute coronary syndrome and chronic heart failure, first adopted in 2000. Both guidelines are scheduled to take effect March 1, 2018. Read More
A Washington state pharmacy used ingredients that are not covered by a designated monograph in compounding drugs, meaning it lost its exemption for labeling requirements, and also failed to maintain sanitary conditions for drug production, the FDA said in a warning letter. Read More
A Wyoming manufacturer of dietary supplements claimed drug-like qualities for its products without obtaining the drug-marketing approvals that such claims require, the FDA said in a warning letter. Read More
Developers of antiviral drugs for prophylaxis and treatment of respiratory syncytial virus should expose at least 100 adults in clinical trials ahead of pediatric studies, the FDA said in new guidance for drugmakers. Read More
Rigorous patient preference information should be part of the FDA’s process to determine risks and benefits of new products, Commissioner Scott Gottlieb said in a statement coinciding with the inaugural meeting of a new advisory committee on patient engagement. Read More