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The Bangladesh High Court has targeted 34 drug firms for ignoring an earlier ban on their products, demanding that they immediately recall their products. Read More
The FDA has finalized a rule that will require pharmaceutical companies to electronically submit, list and register information on finished drug products and active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. Read More
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
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