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The European Commission has updated its GMP guideline on process validation to reflect the EU’s current risk-based approach to managing quality systems over the entire lifecycle of a drug. Read More
Drugmakers exporting drugs from India must now include barcodes on all tertiary and secondary packaging. The policy, intended to assure the safety and effectiveness of therapies reaching patients in the U.S. and elsewhere, affects drugs made on or after April 1, 2015. Read More
Drugmakers in the EU will pay slightly lower fees starting this month, under an annual adjustment that reflects the inflation rate for the previous year Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
A federal judge ordered the FDA to turn over all records concerning Otsuka’s Abilify sNDA to the U.S. district court in Maryland by April 13, saying the agency is attempting to delay litigation over exclusivity of the blockbuster antipsychotic. Read More
Pharmaceutical companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of an approval or rejection of a drug, according to guidance released earlier this month that sets specific timelines for every step of the dispute resolution process. Read More
Mylan is recalling two injectables — a hypertension drug and cancer treatment — due to quality control issues. Both drugs were manufactured in India. Read More
Generics makers may soon have a new way to challenge first-filer marketing exclusivity held by their rivals under certain circumstances after a federal appeals court reinstated a lawsuit from Apotex. Read More
The Centers for Medicare & Medicaid Services has announced that it plans to begin paying for biosimilars through its Part B, Part D and state coverage policies by this summer. Read More