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Clinical Trials › Regulatory Authority

Hogan Lovells

FDA adds information on Commissioner’s National Priority Voucher program

Hogan Lovells on

This week, the U.S. Food and Drug Administration (FDA) posted additional information on its recently announced “Commissioner's National Priority Voucher” (CNPV) program, which will provide up to five vouchers in the program's...more

Barnea Jaffa Lande & Co.

Drug registration reform in Israel: processes are being streamlined and timeframes shortened to increase supply and lower prices

Barnea Jaffa Lande & Co. on

We are living in an era of revolutionary medical innovation, particularly in the research and development of medicinal products. Diseases that were once considered incurable, are now treated with drugs, vaccines and...more

Cooley LLP

Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings

Cooley LLP on

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

Husch Blackwell LLP on

In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

American Conference Institute (ACI) on

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

American Conference Institute (ACI)

[Virtual Event] FDA Boot Camp - September 23rd - 24th, 8:15 am - 12:45 pm EDT

American Conference Institute (ACI) on

For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more

Foley Hoag LLP - Public Companies & the Law

COVID-19 Related Due Diligence for Life Sciences Companies

Foley Hoag LLP - Public Companies & the Law on

Equity Capital Markets are quiet right now given the COVID-19 pandemic. Less than a handful of IPOs priced last week and IPO activity is down almost 20% on a year over year basis. Life sciences initial public offerings have...more

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