FDA aims to speed up biosimilar development and lower drug costs
In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.
FDA
CRN criticizes FDA over drug preclusion ruling
FDA declined to issue guidance or rulemaking, which CRN said will stifle innovation and perpetuate conflict between supplement makers and pharmaceutical companies.
API industry growth accelerates as US drives demand
The US is the largest market for APIs, fueled by high drug use, strong regulation, and top biotech manufacturing.
CHPA disputes autism claims and defends acetaminophen safety
Decades of use, FDA safety reviews, and leading medical groups confirm the safety of acetaminophen when used as directed.
FDA reviews COVID vaccine safety under political pressure
As the agency opens its books and debate intensifies, the future of U.S. vaccine policy and public confidence may depend on how the next week unfolds.
HDA marks DSCSA implementation milestone for distributors
HDA President and CEO Chester “Chip” Davis, Jr. said the achievement represents progress beyond regulatory compliance.
FDA Center heads to take the stage together at CHPA Regulatory Conference
Each year, CHPA’s RSQ Conference unites industry, regulators, and academia to focus on the evolving self-care sector.
FDA wants opioid manufacturers to update prescribing information regarding long-term use
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.
FMI and Consumer Brands issue statement on HHS, FDA color additive announcement
HHS and FDA have announced plans to phase out all petroleum-based synthetic food dyes.
CHPA issues statement on HHS/FDA plans to phase out some synthetic 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.
CHPA releases statement on FDA plans to end animal testing
“We look forward to working collaboratively with FDA and other stakeholders on this important scientific and regulatory paradigm shift,” says the CHPA.
AAM issues statement on FDA job cuts
“Today's staff reductions may undermine the Agency’s ability to approve and ensure the safety of lower-cost generic and biosimilar medicines.”
Massive layoffs at health agencies begin
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.
Industry groups issue statements on confirmation of Dr. Makary as FDA commissioner
The Senate confirmed Dr. Makary's nomination by a vote of 56-44.
FDA drug approvals dip 15.44% in 2024, but smaller pharma leads innovation
Despite the decrease, the landscape of pharmaceutical transformation still remains vibrant.
Compounding pharmacies keep copying Zepbound despite FDA ban
The FDA has yet to comment on how it will proceed. Eli Lilly could pursue legal action against compounding pharmacies.