News & Analysis as of

Regulatory Agenda Life Sciences Coronavirus/COVID-19

McDonnell Boehnen Hulbert & Berghoff LLP

Five Years Ago Today . . .

On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear."  At...more

Sheppard Mullin Richter & Hampton LLP

FDA Dumps Trio of Device-Related Guidances Prior to Administration Change

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more

McDermott+

DEA Releases Long-Awaited Telehealth Special Registration Proposal, but Adoption Is Uncertain

McDermott+ on

On January 15, 2025, the US Drug Enforcement Administration (DEA) released a proposed rule entitled Special Registrations for Telemedicine and Limited State Telemedicine Registrations. This proposed rule would establish three...more

Smart & Biggar

Permanent regulatory framework for COVID-19 medical devices now in force

Smart & Biggar on

On February 22, 2023, amendments to the Medical Devices Regulations (Regulations) came into force that create a permanent regulatory framework for COVID-19 medical devices...more

Morgan Lewis - As Prescribed

FDA Provides Much-Needed Guidance on Master Protocols for COVID-19 Drugs

The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. ...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

In Tuesday's Report: U.S. Senate to vote on relief package, an analysis of how data protection principles relate to vaccine passports...more

Morgan Lewis

Telehealth in the United Kingdom: Considerations for Providers

Morgan Lewis on

With telehealth surging around the globe due to the COVID-19 pandemic, the UK National Health Services has released guidance that provides a set of good practice principles for third-party partners to follow....more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 5

Hogan Lovells on

In Washington: The White House Coronavirus Task Force is warning that there may be a new fast-spreading U.S.A. variant of the coronavirus. "This fall/winter surge has been at nearly twice the rate of rise of cases as the...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

In Tuesday's Report: European Commission proposes far-reaching pharmaceutical strategic plan, Biden names health care nominees, and warnings over Christmas COVID-19 spread....more

Hogan Lovells

EMA publishes list of COVID-19 treatments that have been the subject of the Agency’s guidance

Hogan Lovells on

On 30 October 2020, the European Medicines Agency (“EMA”) published a list containing all COVID-19 treatments and vaccines that have so far been the subject of scientific advice or informal guidance from EMA’s pandemic Task...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

In Tuesday's Report: FDA warns over drug misbranded as COVID-19 treatment; podcast discusses Trump's "Buy American" executive order; an op-ed on the importance of protecting biomedical innovation; HHS sees high level...more

Hogan Lovells

Spain’s AEMPS clarifies position on hydroxychloroquine, echoing statements of EMA and Lancet

Hogan Lovells on

The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to...more

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