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The FDA handed Lupin a warning letter citing the company’s failure to correct cross-contamination issues noted in an inspection of its manufacturing plant in Palghar, India, earlier this year. Read More
Two gene replacement therapies to combat hemophilia are worth multimillion dollar price tags because they would eliminate the need for ongoing treatment with high-priced anticoagulant drugs, says the Institute for Clinical and Economic Review (ICER). Read More
An FDA advisory committee voted 9-0 yesterday in favor of the agency’s proposal to create an as-yet undefined rating system to incentivize drug manufacturers to adopt more mature quality management practices. Read More
A new FDA draft guidance the over-the-counter (OTC) monograph drug user fee program outlines the program’s features and procedures, including the types of fees, due dates, the process for submitting payments, the consequences for failing to pay, and the process for submitting refund requests or disputing the amount of FDA’s assessment. Read More
Novartis has filed a complaint against several generic drugmakers for allegedly infringing on a patent for its blockbuster heart failure drug Entresto (sacubitril/valsartan). Read More
The FDA has revised its October 2017 draft guidance on the Expanded Access program, adding information on eligibility criteria, submission process and safeguards intended to protect patients and preserve the ability to develop meaningful data about the safety and effectiveness of the drug through clinical trials or drug development. Read More
Use of FDA’s expedited approval pathways for new drugs increased from 42 percent in 2008 to more than 75 percent in 2021 — an increase that’s likely to continue as innovative biologic therapies targeting rare diseases seek marketing approval, according to a team of senior FDA officials that recommends the agency exercise caution in speeding new drug approvals. Read More