Camargo
DECEMBER 13, 2021
Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. Product Type-Specific Analysis.
FDA Law Blog
JANUARY 12, 2025
Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Cloudbyz
OCTOBER 19, 2023
The pharmaceutical industry plays a critical role in improving healthcare by developing and bringing new medicines to market. Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. In recent years, the need for a unified clinical trial management platform has become increasingly evident.
XTalks
NOVEMBER 1, 2024
Why it sold so well: Zolgensma is a gene therapy classified as personalized or precision medicine, as it is designed to address specific issues arising from an individual’s unique genetic code. In 2020, Novartis Gene Therapies launched an innovative early access program for Zolgensma, designed to facilitate prompt patient access.
Cloudbyz
FEBRUARY 29, 2024
In the dynamic landscape of pharmacovigilance, where timely and accurate data processing is paramount, the integration of artificial intelligence (AI) technologies has emerged as a game-changer.
Cloudbyz
AUGUST 9, 2023
The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. This is where the platform approach comes into play.
XTalks
AUGUST 2, 2023
Meanwhile, BioMarin’s gene therapy Roctavian is approved by the FDA for the treatment of hemophilia A. 2) Botox Therapeutic/Cosmetic Botox, or botulinum neurotoxin, is a neurotoxic protein produced by the Clostridium botulinum bacteria. But all three drugs have new competitors. Both are anti-CD20 agents. billion in 2022.
Expert insights. Personalized for you.
161 
Let's personalize your content