News & Analysis as of

Life Sciences Public Health Emergency Prescription Drugs

Smart & Biggar

Agile licensing amendments registered

Smart & Biggar on

Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug...more

McDermott+

Exploring the Virtual Care Policy Landscape One Year Post-PHE

McDermott+ on

May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more

Burr & Forman

Telehealth Prescribing Flexibilities for Controlled Substances Extended Through End of 2024

Burr & Forman on

The rule allowing for providers to prescribe controlled substances via telehealth, set to expire for new patient-provider relationships on November 11, has been extended through the end of 2024....more

Sheppard Mullin Richter & Hampton LLP

Tele-Prescribing Flexibilities Extended Again in Second Temporary Rule

This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers...more

Dickinson Wright

DEA Reverses Course and Extends Telehealth Prescriptions of Controlled Substances

Dickinson Wright on

Reversing previously proposed rules, the DEA recently issued new guidance allowing the continued use of telehealth when prescribing controlled substances following the end of the Covid-19 public health emergency (“PHE”)....more

Robinson & Cole LLP

Health Law Diagnosis - DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months

Robinson & Cole LLP on

On May 9, 2023, the Drug Enforcement Administration (DEA) issued a temporary rule that extends pandemic-era flexibilities allowing prescribing of controlled substances based on a telehealth relationship, after receiving in...more

Polsinelli

DEA Temporary Rule Extends Telemedicine Flexibilities Through November 2023 and Grants Additional One-Year Grace Period

Polsinelli on

Two days ahead of the expiration of the COVID-19 Public Health Emergency (PHE), the  Drug Enforcement Agency (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule extending...more

Robinson+Cole Health Law Diagnosis

DEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months

On May 9, 2023, the Drug Enforcement Administration (DEA) issued a temporary rule that extends pandemic-era flexibilities allowing prescribing of controlled substances based on a telehealth relationship, after receiving in...more

Smart & Biggar

New Division 11 of the Food and Drug Regulations: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or...

Smart & Biggar on

Update: Health Canada has prepared an overview of its special access programs, and has finalized the Guidance Document: Sale of Drugs - Public or Canadian Armed Forces Health Emergencies. On February 15, 2023, Regulations...more

Hogan Lovells

Medicines shortages: Dutch Ministry publishes Policy Rule; EMA calls for MAHs to register contact

Hogan Lovells on

With a goal of ensuring medicinal supply interruptions are better managed, the Dutch Ministry’s Policy Rule regarding ‘iron stock’ sets obligations for marketing authorisation holders and wholesalers to keep a minimum safety...more

Knobbe Martens

U.S. FDA Approves Monkeypox Treatment Formulation

Knobbe Martens on

(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of...more

Hogan Lovells

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

Hogan Lovells on

Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

Hogan Lovells

FDA advises drug manufacturers on best practices for restarting operations during COVID-19 pandemic

Hogan Lovells on

On September 11, the U.S. Food and Drug Administration (FDA) issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” urging drug manufacturers to...more

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