by Pill Pals Customer Service | Mar 27, 2025 | News
Each year, CDER receives more than 300,000 submissions, amounting to millions of pieces of data. CDER reviews the data to bring lifesaving new drugs to market while protecting public health. The data can arrive in a wide variety of formats and even on paper,...
by Pill Pals Customer Service | Mar 26, 2025 | News
Summary Company Announcement Date: March 25, 2025 FDA Publish Date: March 26, 2025 Product Type: Cosmetics Hair Products Reason for Announcement: Recall Reason Description Potential to be contaminated with the bacteria, Klebsiella oxytoca Company Name: Henkel Capital...
by Pill Pals Customer Service | Mar 26, 2025 | News
Clinical trials are studies of drugs and biologics that are still in development and have not yet been approved by the FDA. Many patients enroll in clinical trials to gain access to investigational therapies and contribute to finding out how well an investigational...
by Pill Pals Customer Service | Mar 26, 2025 | News
The Biologics Effectiveness and Safety (BEST) System was launched in October 2017 to expand and enhance CBER access to new and better data sources, methods, tools, expertise and infrastructure to conduct surveillance and epidemiologic studies. BEST is part of the...
by Pill Pals Customer Service | Mar 26, 2025 | News
Regenerative medicine therapies (RMTs) are defined in section 506(g)(8) of the Food Drug & Cosmetic Act as including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or...
by Pill Pals Customer Service | Mar 26, 2025 | News
STN: 125508Proper Name: Human Papillomavirus 9-valent Vaccine, RecombinantTradename: GARDASIL 9Manufacturer: Merck Sharp & Dohme LLCIndications: Indicated in girls and women 9 through 45 years of age for the prevention of the following diseases: Cervical,...
by Pill Pals Customer Service | Mar 26, 2025 | News
On March 26, 2025, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic...
by Pill Pals Customer Service | Mar 26, 2025 | News
Image CBER’s Policies, Procedures, and Review ResourcesThis webpage provides important resources related to the regulatory framework of products regulated by CBER, including policies, procedures, and review resources.CBER reviews applications for new products, new...
by Pill Pals Customer Service | Mar 26, 2025 | News
FDA publishes a variety of lists and reports on generic drug application activities for public awareness, including: Content current as of: 03/26/2025...
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