Bill of Health

JUNE 12, 2023

Food and Drug Administration (FDA), in fulfilling its task of ensuring that drugs are safe and effective, has recently turned its attention to the growing use of artificial intelligence (AI) and machine learning (ML) in drug development. By Matthew Chun The U.S. manufacturing process design), implement advanced process controls (e.g.,

FDA 261

FDA Governance 261

Bill of Health

APRIL 24, 2023

Regulatory and patent exclusivity periods govern the timing of generic entry, and because market share and revenue is often quickly lost upon market entry of generic drugs, extending market exclusivity for any duration can be extremely profitable. Glenn Cohen’s Health Law Policy, Bioethics, and Biotechnology Workshop at HLS.

Public Health 313

Public Health FDA Bioethics Governance 313

Bill of Health

NOVEMBER 30, 2022

Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public. healthcare system, representing just one example of “healthcare federalism” — the division of power between the federal and state governments in the regulation of health care. After Dobbs , U.S.

FDA 176

FDA Bioethics Public Health Governance 176

Healthcare Law Blog

MAY 31, 2022

Medical devices are regulated by the Food and Drug Administration (“FDA”) and many of the applications and technologies used to deliver or access healthcare in the metaverse may be classified as a medical device. [3] 4] CDRH Proposed Guidances for Fiscal Year 2022 (FY2022) | FDA. [5] Medical Device Regulations. Healthcare Laws.

FDA 90

FDA HIPAA Medicare Medicare 90

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections.

FDA 40

FDA Compliance Licensing World Health 40

C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

Medicaid 104

Medicaid Medicaid Medicare Medicare 104