cnbctv185h
Alembic Pharma's Vadodara unit passes FDA test with VAI remark
Voluntary action indicated (VAI) is suggested when violations are found, but the problems do not justify further regulatory ...
manilatimes6h
Kexing Biopharm Obtained IND Approval for Its Self-developed GB05 from U.S. FDA
Kexing Biopharm Co., Ltd. (Stock Code: 688136.SH) recently announced that the Investigational New Drug Application (IND) of GB05, Human Interferon α1b Inhalation Solution, a self-developed product by ...
thehealthy20h
RFK Jr.’s New Role Will Likely Change 6 Longstanding FDA Practices, Says National Expert
A seasoned FDA compliance and regulations expert says you can watch for these major ways health intelligence may change for the public.
Outset Medical announces resolution of FDA warning letter
Outset Medical (OM) announced it has been notified by the FDA that all issues cited in a warning letter the company received in July of 2023 ...
Produce Blue Book1d
Your company may not be as FSMA 204 compliant as you think
Most people know the FDA has set a January 2026 enforcement deadline for compliance with FSMA 204, which requires ...
FedScoop1d
Federal judge orders HHS, CDC, FDA to restore webpages, datasets
The three health agencies were directed to restore those websites as they were Jan. 30 by the end of the day Tuesday.
JD Supra2d
FDA Publishes Rule Updating ‘Healthy’ Nutrient Content Claim
On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food ...
Judge orders HHS, CDC and FDA to restore deleted webpages with health information
The NGO Doctors for America argued that HHS, CDC and FDA violated federal law in removing medical information from ...
JD Supra2d
Compliance into the Weeds: End of FCPA and CFPB?
The award-winning Compliance into the Weeds is the only weekly podcast that takes a deep dive into a compliance-related topic, literally going ...
The National Law Review3d
CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices
Contec Medical Systems (“Contec”), a global medical device and healthcare solutions company headquartered in China, sells ...
Food3d
What does FDA’s freeze mean for the food industry?
While a pause on federal health agencies is nothing new during presidential transitions, the Trump Administration’s ...
The National Law Review4d
Proposed FDA Rule May Require Stricter Testing for Talc in Cosmetic Products
Recent federal developments may soon require cosmetic companies to adopt stringent precautions to ensure that talc-containing ...