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.
Generics maker Apotex has sued Health Canada over its ban of the company’s products from India, alleging the agency is enforcing the ban to blunt criticism against it by leaders in parliament and a national newspaper rather than in response to any legitimate quality manufacturing issues. Read More
Inspections of U.S. pharmaceutical manufacturing facilities have seen a declining number of official warnings over the past five years, but the trend is less clear on the international front. Read More
Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline. Read More
The FDA plans to more than triple its staff in China from eight direct hires to 26, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S. Read More
With drugmakers facing a Jan. 1 deadline to begin complying with new product track-and-trace requirements, the FDA has announced a wide range of options that companies can choose from to satisfy the new law in a short guidance that contains no surprises for industry. Read More
The FDA is requiring drugmakers to revamp their product labeling to include clearer information on the safe use of drugs and biologicals in pregnant women and nursing mothers, marking the first labeling requirement of its kind since the late 1970s. Read More
Compounding pharmacies are warning that a federal drug safety law is starting to hamper their ability to supply needed therapies to patients, and that a strict reading of the law could cause even greater hurdles to producing the products. Read More
The FDA is considering a new inspection scoring system that would for the first time recognize drugmakers that go beyond normal compliance with good manufacturing practices. Read More