News & Analysis as of

Abbreviated New Drug Application (ANDA) › GDUFA

King & Spalding

Not Quite the Titanic: The Food and Drug Omnibus Reform Act Rescues Some FDA Policy Initiatives

King & Spalding on

The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more

Latham & Watkins LLP

Continuing Appropriations Act Includes FDA Reauthorization of User Fees

Latham & Watkins LLP on

The Act reauthorizes FDA’s user fee programs but omits several proposed reforms to the FDA regulatory framework, setting the stage for further negotiations in Congress. Key Points: ..Congress authorized FDA to...more

Morgan Lewis - As Prescribed

FDA’s OGD Publishes Guidance Documents to Hasten Market Entry of Generic Drugs

Morgan Lewis - As Prescribed on

While the Biden administration and US Congress continue to debate ways to address perceived prescription drug pricing concerns, the Food and Drug Administration (FDA) is taking action. Under its Drug Competition Action Plan...more

Arnall Golden Gregory LLP

How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II

Arnall Golden Gregory LLP on

FDA recently issued two draft guidances: Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which...more

Latham & Watkins LLP

FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding

Latham & Watkins LLP on

Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines. Key Points: ..Congress authorized FDA to collect increased total annual user...more

Mintz - Health Care Viewpoints

FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention

Mintz - Health Care Viewpoints on

It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As...more

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