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Companies planning to market a botanical drug under an NDA must be able to prove the therapeutic consistency of the product, since the potential for variation is critical, the FDA says. Read More
AbbVie is launching new attacks on the FDA’s approach to biosimilar labeling, arguing in a letter posted to regulations.gov that the labels have “indefensible” omissions of how biosimilars and brandname biologics differ. Read More
India’s prime minister has approved a $270 million plan to strengthen the country’s drug regulatory system, including establishing new drug testing laboratories and a training academy for regulatory and drug testing officials. Read More
Drugmakers are seeking clarification on the use of in vitro studies to assess the effects of active pharmaceutical ingredients taken by men on their potential offspring. Read More
Drugmakers in Australia are urging the Therapeutic Goods Administration to raise the number of patients required for classifying an orphan disease, saying it would bring the threshold in line with the EU, Canada and Switzerland. Read More
The Indian government is considering establishing a $78 million venture capital fund to offer loans to drug companies that are building or expanding manufacturing facilities. Read More