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Food and Drug Administration (FDA) › FDA Approval › Investigational New Drug Application (IND)

Rothwell, Figg, Ernst & Manbeck, P.C.

Gene Therapy Approvals Gain Steam in 2023: FDA Approves First Gene Therapies for Sickle Cell Disease

Rothwell, Figg, Ernst & Manbeck, P.C. on

In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more

Arnall Golden Gregory LLP

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

Arnall Golden Gregory LLP on

In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

Epstein Becker & Green

In Response to COVID-19, FDA Extends Enforcement Discretion for HCT/Ps Requiring Pre-Market Review

Epstein Becker & Green on

On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the...more

Hogan Lovells

New drug marketing applications: how do EMA and FDA compare?

Hogan Lovells on

A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more

Mintz - Health Care Viewpoints

Congress Looking to Streamline CBD Drug Research

Mintz - Health Care Viewpoints on

We’ve previously blogged about the regulation of CBD by the Food and Drug Administration (FDA), and it appears that the dialogue around CBD isn’t slowing down as we continue through the second half of 2019. Recently, a...more

Stinson - Corporate & Securities Law Blog

SEC Charges Issuer for Reg FD Violation for Selective Disclosure to Analysts

Stinson - Corporate & Securities Law Blog on

The SEC charged TherapeuticsMD Inc., a pharmaceutical company headquartered in Boca Raton, Florida, with violations of Regulation FD based on its sharing of material, nonpublic information with sell-side research analysts...more

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

Verrill on

On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

Hogan Lovells

FDA’s Proposed New Pathway for Devices Referencing Drugs (DRDs)

Hogan Lovells on

The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable regulatory pathway for devices that seek to use older, mainly generic drugs in...more

Troutman Pepper

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

Troutman Pepper on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

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