A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
India’s patent laws are coming under more intense scrutiny, with cases that could add new difficulties for foreign multinational companies. India’s Supreme Court is wrapping up a case between Novartis and the Indian patent office. The case centers on whether the company’s patent for its cancer drug Glivec (imatinib mesylate) is viable in India under the Patents Amendment Act of 2005. Generic Line