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.
In a preview of how the FDA’s Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues early in the review cycle. Read More
Manufacturers of prescription and over-the-counter drugs containing acetaminophen should warn patients about the risk of serious skin reactions, according to an FDA draft guidance. Read More
The FDA wants to make it easier for generics firms to acquire samples from brandmakers who claim drug safety protocols prevent them from selling the products for bioequivalence testing. Read More
Brazil is providing more clarity around voluntary public-private partnerships that aim to expand access to affordable drugs, but questions remain about transparency of the program and the division of markets between competing partnerships. Read More
The FDA says it plans soon to release new guidance on complying with product track-and-trace requirements that kick in Jan. 1, but industry says the agency also should strengthen rules that clarify that federal regulations preempt state laws. Read More
Canadian regulators will have sweeping new powers to order drug recalls, require labeling changes and postmarket studies, and release confidential business information under a rewrite of the country’s drug safety law. 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
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
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
Manufacturers developing biosimilars in Europe want regulators to go back to comparing their therapies with the reference product, based on the actual amount of active ingredient in a dose, rather than a proposed standard that compares dosages and routes of administration. Read More