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A new FDA draft guidance the over-the-counter (OTC) monograph drug user fee program outlines the program’s features and procedures, including the types of fees, due dates, the process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The FDA has revised its October 2017 draft guidance on the Expanded Access program, adding information on eligibility criteria, submission process and safeguards intended to protect patients and preserve the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
The EMA panel recommended that JAK inhibitors be used cautiously, if at all, in patients who are age 65 years and older, at increased risk of major cardiovascular problems, past and current smokers or those with a history of cancer. Read More
The FDA clarifies its regulatory requirements for small entity establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/P), in a final guidance released today. Read More
In a draft guidance released today, the FDA says trials of drugs for pediatric use should train clinical investigators and trial staff to measure and evaluate the drug’s potential impact on participants’ physical growth and sexual development. Read More
The FDA has issued a Deferred Action letter for Amicus Therapeutics’ biologic license application (BLA) for cipaglucosidase alfa, the biologic component of AT-GAA, its investigational dual therapy for muscle-wasting Pompe disease. Read More