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FDA Looks Inside For Chief Counsel, Taps Elizabeth Dickinson

 
• By Brenda Sandburg

Former FDA attorneys laud her appointment, saying she is highly regarded inside and outside the agency for her intelligence, warmth and expertise on Hatch-Waxman and other key issues.

FDA’s decision to make Elizabeth Dickinson permanent chief counsel was welcome news to those within and outside the agency, who hailed her as the perfect person to oversee the raft of legal issues confronting the agency.

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More from United States

Proposed HHS Budget Would Eliminate Medicare Negotiation Program Start-Up Funding

 
• By Cathy Kelly

The preliminary budget document supports legislation clawing back funds appropriated for the program.

FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart

 
• By Sue Sutter and Derrick Gingery

Lowell Zeta, a senior counselor at the FDA from 2020 to 2021, returns as deputy commissioner for strategic initiatives. The agency also names a new acting CIO and acting CVM director, but OGD's Ted Sherwood and OPDP's Catherine Gray retired.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines

 
• By Bridget Silverman

US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease

More from North America

US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases

 
• By Sarah Karlin-Smith

Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.

Confirmatory Trials: Industry Wants Timely Protocol Feedback, More Clarity On ‘Due Diligence’

 
• By Sue Sutter

Consumer and academic group comments on accelerated approval and confirmatory trial guidances say the proposed criteria for determining when a study is underway are too vague.

Chikungunya At US CDC: Bavarian Nordic’s Vimkunya Recommended, Valneva’s Ixchiq Adjusted

 
• By Bridget Silverman

Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.