We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Drugmakers doing business in India should prepare for price caps on more drugs as the National Pharmaceutical Pricing Authority rushes to complete price fixes on 98 essential drugs. Read More
Manufacturers of influenza vaccines may obtain marketing authorization in the EU based on less-than-comprehensive applications if they supplement their filings with clinical trial data after a pandemic is declared, the European Medicines Agency says. Read More
The European Medicines Agency is launching a 12-month pilot program to improve the usefulness of postmarket safety data by giving drugmakers targeted advice on postmarket study design. Read More