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.
The FDA has issued a public health advisory to healthcare providers after the European Medicines Evaluation Agency mandated that AstraZeneca make changes to labeling for its cholesterol drug Crestor.
The FDA has signed a contract with an independent consultant to examine why first-cycle drug reviews fail, the head of the Center for Drug Evaluation and Research (CDER) said late Tuesday at the Biotechnology Industry Organization’s annual convention in San Francisco.
The Centers for Medicare & Medicaid Services (CMS) and the National Cancer Institute (NCI) announced they will collaborate to speed up the process for bringing new anticancer drugs to patients.
The pharmaceutical industry is not complying with a statute that mandates data on industry-sponsored cancer clinical trials be reported to a federal website, according to a powerful House lawmaker.
The FDA has issued warning letters to five pharmacies that compound human prescription drugs containing the unapproved active pharmaceutical ingredient (API) domperidone.
The FDA has released a revised guidance document spelling out when new drug applications (NDAs) for the marketing of botanical drug products are required and when such a product can be marketed under an OTC drug monograph.
The FDA has released an International Conference on Harmonisation guidance addressing issues related to the quality section of the common technical document (CTD-Q).
Medicare beneficiaries using the new drug discount cards can save between 46 percent and 92 percent on many commonly used prescription drugs if they buy generics instead of brand drugs, a study by the Centers for Medicare & Medicaid Services (CMS) found.
The FDA’s decision to cancel its June 11 public meeting to address possible Part 11 rule revisions has exacerbated an already confused situation in which industry has been unable to get a clear fix on the agency’s direction regarding electronic signatures and electronic recordkeeping.