Encouraging Competition Through Generic Drugs
FDA clarifies its generic drug approval process in an effort to encourage market competition.
Combatting Covert Chemistry Operations
To curb overdoses and drug trafficking, the DEA proposes regulations for a chemical precursor to fentanyl.
Proposal to Import Prescription Drugs Faces Criticism
Critics of a proposed rule to import drugs from Canada cite safety concerns and other potential problems.
FDA Versus Our Own Stem Cells
The federal government seeks authority over stem cell treatments but risks thwarting medical advancement.
FDA Relaxes Rules on Ventilators for COVID-19
Responding to the coronavirus outbreak, a federal agency relaxes requirements on medical device manufacturers.
An Epidemic Meets a Pandemic
Amid the coronavirus, the federal government eases restrictions on prescribing controlled substances by telehealth.
Before the Bedside Manner
Health care licensing regulators grapple with innovation, safety, and expertise when credentialing providers.
Will FDA Guidance Hasten Testing for COVID-19?
In the face of a massive viral outbreak, a federal regulator issues unprecedented guidance on validating COVID-19 testing.
The Regulatory Race Against a Public Health Crisis
The federal government responds to the coronavirus pandemic by amending its foreign quarantine rules.
Can the U.S. Outpace Disease Outbreaks?
In the United States, disease outbreaks challenge emergency preparedness.
Resolving Regulatory Confusion Over Medical Software
FDA clarifies enforcement priorities for medical device clinical decision support software.