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.
FDA Commissioner Scott Gottlieb outlined an action plan to remove barriers to generic competition, saying agency regulations have been “gamed” by brand-name manufacturers to delay generic drug approvals even after patents and exclusivity periods lapse. Read More
In a decision that reshapes the patent dance between biosimilar applicants and reference holders — and could affect the course of billions of dollars in the pharmaceutical industry — the U.S. Supreme Court ruled biosimilar manufacturers do not have to wait for FDA approval before beginning a six-month delay on commercial marketing. Read More
The FDA implemented a new policy to expedite generic drug reviews in areas of limited competition, and published a list of off-patent branded drugs with no approved alternatives, as the first steps in the agency’s action plan to help lower the costs of prescription drugs. Read More
CBER added several topics to its guidance agenda for 2017 in its mid-year update, including blood donor requalification and the use of certain serum tests in reducing infection transmission. Read More
An industry-funded group has petitioned the FDA to fully transition to opioid painkillers with abuse-deterrent labeling, and to require manufacturers to convert their non-deterrent products. Read More
Years of legal wrangling came to a close with Allergan agreeing to a $13 million settlement for claims the company illegally promoted eye drugs by providing consulting and other services to doctors. Read More
A Chinese heparin contract testing lab has been warned by the FDA for significant cGMP violations, recalling unresolved questions and concerns from the Chinese heparin scandal a decade ago. Read More
The European Medicines Agency and the European Network for Health Technology Assessment have developed a joint platform for parallel consultations on evidence plans for marketing authorizations and health technology assessments to provide sponsors with simultaneous, coordinated advice on development strategies. Read More
The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance. Read More
Following the U.S. Supreme Court’s defining decision on the biosimilar “patent dance” and approval process, Sandoz has requested that an unresolved part of its case against Amgen return to a California federal district court. Read More
Three unapproved ingredients and a host of labeling and other GMP violations have resulted in an FDA warning letter for a Texas-based supplement company. Read More