News & Analysis as of

Therapeutic Services Food and Drug Administration (FDA)

Wilson Sonsini Goodrich & Rosati

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

Nelson Hardiman, LLP

Too Much Of A Good Thing?

Nelson Hardiman, LLP on

F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor...more

Bradley Arant Boult Cummings LLP

2023: A Good Trip Around the Sun for Psychedelics

2023 was a momentous year for psychedelics, and it’s not just because we at Budding Trends started writing about them. There were wins for the psychedelic industry at the local, state, and federal levels, as well as in the...more

Goodwin

Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies

Goodwin on

​​​​​​​Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren are joined by Emily Chee, the US General Manager of Novartis Gene Therapies, a biotech company specializing in gene therapies for rare...more

Hogan Lovells

The next era of digital therapeutics

Hogan Lovells on

Products incorporating artificial intelligence/machine learning (AI/ML) algorithms have enormous potential for health care. The power of AI can enhance the capabilities of software that has the potential to benefit more...more

Morgan Lewis

FDA Regulation of COVID-19 Apps, Digital Therapeutics, and Other Digital Health Technologies

Morgan Lewis on

With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19...more

McDermott Will & Emery

FDA Issues Enforcement Policy for Digital Health Therapeutic Devices for Psychiatric Disorders During COVID-19

McDermott Will & Emery on

The Food and Drug Administration issued an enforcement policy on the use of digital health devices that are considered therapeutic for psychiatric disorders during the Coronavirus (COVID-19) public health emergency. The...more

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