Healio

FDA issues draft guidelines for non-opioid solutions to chronic pain

Please provide your email address to receive an email when new articles are posted on . The guidelines address issues related to development and prescription of non-opioid pain drugs. They are part of ...
MedTech Dive

4 questions about the FDA’s approach to generative AI

The medtech industry is awaiting FDA guidance on generative AI. The agency has sought feedback in advisory meetings and a ...

The FDA Just Updated Its Guidance for Bagged Lettuce, Cut Fruit, and Other Ready-to-Eat Produce

Because fresh-cut produce doesn’t undergo a final step to eliminate harmful pathogens, the agency’s recommendations emphasize preventing contamination throughout the production process.
JD Supra

FDA’s New Psychedelic Drug Guidance Paves a Path to Approval While Setting a High Evidentiary Bar

On July 13, 2026, the U.S. Food and Drug Administration (“FDA” or “Agency”) finalized its guidance on “Psychedelic Drugs: Considerations for Clinical Investigations,” replacing the June 2023 draft ...
RAPS

FDA finalizes guidance on assessing bioequivalence of topical drugs

FDA finalizes guidance on assessing bioequivalence of topical drugs The US Food and Drug Administration (FDA) has finalized guidance for manufacturers on using physicochemical and structural (Q3) ...
Regulatory Affairs Professionals Society

Industry asks FDA to expand prior knowledge guidance

Industry stakeholders want the US Food and Drug Administration (FDA) to expand the scope of its recent draft guidance on the ...
FierceBiotech

FDA outlines draft policy on MRD, complete response for accelerated approvals in multiple myeloma

After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...
Fox News

Trump administration to unveil new dietary guidelines as FDA plans sweeping 2026 food overhaul

The Trump administration is preparing to roll out new dietary guidelines for Americans in early January, a move Food and Drug Administration (FDA) officials say will kick off a broader food policy ...
CNBC

FDA proposes new system for approving customized drugs and therapies for rare diseases

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...
Healio

FDA-identified uncertainties about new cancer drugs often omitted in journals, guidelines

Please provide your email address to receive an email when new articles are posted on . The FDA frequently identifies uncertainties about newly approved cancer drugs, but they are often omitted in ...
Medical Xpress

Implementing all recommended drug guidelines for heart failure could reduce hospitalizations and cut costs

Patients hospitalized with a common form of heart failure could avoid later hospital stays—and dramatically lower health care costs—if they receive the full combination of four medications currently ...