These changes follow a public advisory committee meeting in May that reviewed data showing serious risks—such as misuse, addiction, and both fatal and non-fatal overdoses—for patients who use opioids over long periods.
HHS and FDA have announced plans to phase out all petroleum-based synthetic food dyes.
The FDA and HHS have announced plans to phase out petroleum-based synthetic dyes from the national food supply and replace them with natural ingredients.
“We look forward to working collaboratively with FDA and other stakeholders on this important scientific and regulatory paradigm shift,” says the CHPA.
“Today's staff reductions may undermine the Agency’s ability to approve and ensure the safety of lower-cost generic and biosimilar medicines.”
The widespread layoffs and restructuring efforts have raised concerns about these agencies' future capacity to respond to public health crises, regulate critical medical products, and conduct essential research.
The Senate confirmed Dr. Makary's nomination by a vote of 56-44.
Despite the decrease, the landscape of pharmaceutical transformation still remains vibrant.
The FDA has yet to comment on how it will proceed. Eli Lilly could pursue legal action against compounding pharmacies.
The initiative seeks to revise the FDA’s “Generally Recognized as Safe” (GRAS) Final Rule.
Novo Nordisk has increased manufacturing, running production facilities 24/7 to ensure steady shipments to wholesalers.
Jones pointed to the layoffs of 89 staffers in the food division, cuts he called “indiscriminate.”
Journavx is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years.
BridgeBio Pharma has received FDA approval for a new drug for a rare heart disease after very promising trials.
Johnson & Johnson has submitted an FDA application for the first subcutaneous IL-23 inhibitor for ulcerative colitis. This drug could offer patients a groundbreaking at-home treatment option.
Currently, oral phenylephrine is widely used as a nasal decongestant active ingredient in many O-T-C monograph drug products.
