RAPS

FDA kicks off GDUFA III reauthorization process

In a public meeting held via webcast, officials of the US Food and Drug Administration (FDA) kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which ...
RAPS

Guidance details updated FDA GDUFA fees, structure and appeals process

The US Food and Drug Administration (FDA) published a final guidance last week that updates the agency’s user fee structure and other aspects of the Generic Drug User Fee Amendments (GDUFA III) deal ...
JD Supra

FDA Issues Draft Guidance on Post-Warning Letter Meeting Requests Under GDUFA

On September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team ...
JD Supra

FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round

As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this ...
FiercePharma

FDA provides GDUFA guidance; Lilly bets big on continuous processing; Edible tags noted for fighting counterfeits;

> Eli Lilly ($LLY) by next year expects to be using four different continuous processing platforms for production of many of its new products. Story > The University ...
WFLA News Channel 8

Senate pushes FDA to clear 3,500+ generic prescription drugs in backlog

WASHINGTON (MEDIA GENERAL) – More than 3,500 new generic prescription drugs currently sit on shelves, fully developed, awaiting FDA approval. Now, U.S. senators are applying pressure for the agency to ...