To shed light on the regulatory requirements for production of co-crystals, the FDA is offering drugmakers submitting ANDAs and NDAs a clearer definition of co-crystals that no longer denotes them as an in-process material. Read More

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

The European Chemicals Agency (ECHA) has given Novartis authorization to use the toxic chemical diglyme after its scheduled ban in 2017. 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