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The FDA will agree to meet to discuss the ANDA deficiencies cited in a complete response letter to a sponsor only if the sponsor lists the questions it wants to raise and the people who will participate in the meeting and includes other items spelled out by the agency in draft guidance, the FDA said. Read More
For fiscal 2017, the FDA approved 763 generic drug applications, beating the previous year’s record of 651 by 17 percent. An additional 174 were granted tentative approval. Read More
The FDA published new product-specific draft guidances for 30 active ingredients — including cancer therapies, asthma treatments, epinephrine auto-injectors and anti-infectives — outlining the agency’s preferred methods for supporting ANDA submissions. Read More
The Federal Circuit eased the ability for patent holders to amend their claims when challenged under inter partes review — a hurdle that pharmaceutical industry trade groups had previously described as unfair, ambiguous and impractical. Read More
The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay, and how to request reconsiderations of user fee assessments. Read More
The FDA published a new manual of policies and procedures for reviewing staff, detailing how the agency will communicate ANDA deficiencies with applicants — meeting one of its first commitments for the next generation of GDUFA. Read More
The FDA warned investigational medical device sponsor UVLrx Therapeutics for failing to obtain required authorization from its Institutional Review Board. Read More
In a significant policy shift, China plans to accept data from foreign clinical trials in its drug approval process if the drug is already approved overseas. Read More
The FDA finalized its guidance on developing direct-acting antivirals for chronic hepatitis C, outlining Phase III trial design options, enrollment criteria and safety evaluations for specific patient populations. Read More
The FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement. Read More