Philly scientists helped shape proposed FDA guidance that could accelerate gene therapies for rare diseases

The new draft guidance could enable more personalized treatments like the first-of-its-kind gene-editing therapy developed ...
Regulatory Affairs Professionals Society

FDA slashes number of analytical tests for IVDs used in public health emergencies

The US Food and Drug Administration (FDA) on Monday finalized guidance to assist manufacturers in validating in vitro ...

FDA unveils guidance for ‘plug and play’ gene therapies

The plan advances recent agency moves to accelerate “personalized” treatments by offering an approval framework for therapies ...

FDA draft guidance aims to speed personalized gene therapies for rare diseases

The US FDA has unveiled draft guidance designed to assist rare disease therapy developers by providing regulatory clarity in ...
The Healthy @Reader's Digest on MSN

Here’s what the FDA and CDC’s differing COVID vaccine guidelines mean for you and your family

Immunology experts offer clarity and explain the different verdicts. Plus, learn what you should know before heading to the pharmacy.
BioSpace

New FDA draft guidance doubles down on expediting approvals of personalized gene therapies

The FDA has outlined a process for allowing a single application to cover multiple variants of a gene therapy. At the same ...
Regulatory Affairs Professionals Society

FDA revises guidance on essential drug delivery device performance

The US Food and Drug Administration (FDA) issued revised draft guidance on Thursday aimed at assisting sponsors of ...
JD Supra

FDA Finalizes Potency Assurance Guidance For Cellular And Gene Therapy Products: Key Implications For Companies

On November 3, 2026, the United States Food and Drug Administration (FDA) finalized its December 2023 draft guidance Potency Assurance for ...
FiercePharma

FDA finalizes guidance on promotional materials for biologics and biosimilars

Though the guidance document outlines recommendations suggested by the FDA for compliance with its requirements, it’s legally nonbinding. (Photo By Al Drago/CQ Roll Call) A new guidance document ...
Targeted Oncology

FDA Finalizes Potency Guidance for Cell and Gene Therapy Products

FDA final guidance sets a risk-based potency assurance roadmap for cell and gene therapies, spanning development, ...
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 ...