Biotecnología

Biotecnología

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
03/02/2023 - The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.
Public Notification: MANNERS Energy Boost contains hidden drug ingredient
03/02/2023 - The Food and Drug Administration is advising consumers not to purchase or use MANNERS Energy Boost, a product promoted and sold to boost energy on www.amazon.com and possibly in some retail stores.
CARBOGEN AMCIS Opens Sterile Liquid Drug Product Mfg. Facility in France
03/02/2023 - New facility increases product development and manufacturing capacity for liquid and freeze-dried products.
Mikart Invests in New Liquids and Suspensions Suite
02/02/2023 - Enhances liquid oral drug product development and manufacturing capabilities of complex formulations.
Aprecia Names Owen Murray as Its CEO
02/02/2023 - Most recently served in VP role at Recordati Rare Diseases.
Lonza Breaks Ground on Commercial Drug Product Facility in Stein
02/02/2023 - Milestone for the development of Lonza’s first large-scale drug product manufacturing facility based in Stein.
Andelyn Biosciences, Odylia Therapeutics Partner to Manufacture Gene Therapy for Vision Loss
02/02/2023 - Novel AAV capsid Anc80 enables efficient gene transfer.
Notice of Updates
01/02/2023 - Webpage providing notices of updates to FDA's STIC webpages for antibacterial and antifungal drugs.
Drug Quality Sampling and Testing Programs
01/02/2023 - FDA CDER's quality sampling and testing programs assess pharmaceutical quality after drugs are on the market.
FDA Roundup: January 31, 2023
01/02/2023 - The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Multilingual COVID-19 Resources
31/01/2023 - The U.S. Centers for Disease Control and Prevention (CDC), and international and U.S. Government partners including FDA, are addressing an outbreak of coronavirus disease 2019 (COVID-19).
Have You Given Blood Lately?
31/01/2023 - FDA works to ensure the safety of the more than 14 million units of blood and blood components donated in the U.S. each year. Learn how FDA helps safeguard the blood supply and how you can donate...
Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use - 08/10/2022
31/01/2023 - Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
Competitive Generic Therapy Approvals
31/01/2023 - A list of all FDA-approved abbreviated new drug applications for drug products that received a Competitive Generic Therapy designation under section 506H of the Federal Food, Drug, and Cosmetic Act.
New Drug Therapy Approvals 2019
31/01/2023 - Summary of FDA Center for Drug Evaluation and Research’s approvals of novel drug therapies along with approvals for biosimilars and other new approvals.
The Center for Research on Complex Generics
30/01/2023 - FDA awards a 5-year grant to the University of Maryland and the University of Michigan to establish a Center for Research on Complex Generics (CRCG).
Forge Biologics Strengthens Genetic Medicine CDMO Capabilities
30/01/2023 - New leadership team appointments strengthen manufacturing capabilities with a focus on gene therapy clinical and commercial cGMP manufacturing.
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA - 02/24/2022
30/01/2023 - Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts
30/01/2023 - The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020 to aid response efforts and ease the economic impact of COVID-19.
Catalent Bolsters Cell and Gene Services
30/01/2023 - Launches new service for end-to-end supply chain case management of cell and gene therapies.