RAPS

Drug-Drug Interactions: FDA Issues Guidance on Clinical, In Vitro Studies

The US Food and Drug Administration (FDA) on Thursday finalized two guidances providing recommendations to drugmakers on evaluating potential drug-drug interactions (DDIs) for new drugs through ...
RAPS

FDA drafts guidance on drug interaction labeling

The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and ...
BioSpace

FDA’s CRL transparency policy is boosting biopharma accountability

Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more ...
BioSpace

FDA flexibility isn’t absent but evolving regulations come with growing pains

The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare ...
Medscape

FDA to Consumers: Don’t Use These Hyaluronic Acid Products

The FDA has issued an advisory to consumers, urging them not to buy or use an array of products that, on labeling, contain ...