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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The FDA published a draft guidance explaining the new GDUFA fee structure and the types of fees that took effect Oct. 1.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
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
An FDA advisory committee voted 10-0 in favor of the efficacy of a drug candidate for treatment of glaucoma and ocular hypertension based on data from efficacy trials. Read More
Developers of antiviral drugs for prophylaxis and treatment of respiratory syncytial virus should expose at least 100 adults in clinical trials ahead of pediatric studies, the FDA said in new guidance for drugmakers. Read More
The Association of Clinical Research Organizations warned that the state of New Jersey’s plan to cap drugmaker payments to doctors could hurt clinical trials. Read More
The FDA could further improve the transparency of its benefit-risk assessments in drug regulatory decisions by disclosing more information in complete response letters, BIO suggested in written comments to the agency. Read More
The FDA published a draft guidance explaining the new biosimilar fee structure under BsUFA II and the types of fees that took effect Oct. 1.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 fee assessments. Read More
Commissioner Scott Gottlieb said there’s no better time for him to work at the FDA, with a slate of new agency authorities providing a “watershed opportunity” to shape the regulatory process. Read More
The plan’s objectives cover early dialogue and scientific advice processes, information exchange at market entry and generating data following product authorization. Read More