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The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has effectively banned products from a Pfizer plant in India after a joint inspection by the FDA, MHRA, Australia’s Therapeutic Goods Administration and Health Canada, the first joint investigation by the four agencies. Read More
Product claims on three companies’ websites led the FDA to issue warning letters declaring that the products have not been tested in human trials and cannot be advertised as bestowing health benefits. Read More
Clinical trials to prove biosimilar interchangeability with reference products will likely involve multiple switches between the products, an industry expert said. Read More
Celator Pharmaceuticals has received a drug enforcement promotion letter as a result of a drug it showcased during the annual meeting of the American Society of Clinical Oncology (ASCO). Read More
An FDA inspection found microbiological contamination of drugs purporting to be sterile at a Bausch & Lomb manufacturing facility in Florida, according to a Form 483 handed to the company. Read More