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.
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.
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.
Bone Biologics Engages Avania for NB1 Clinical Trial
30/01/2023 - Trial will evaluate the safety and effectiveness of Bone Biologic’s novel NB1 in patients with degenerative disc disease.
US-Canada Regional ICH Consultation - 05/11/2022
30/01/2023 - FDA and Health Canada will be co-hosting a regional public meeting to provide information and solicit input prior to the next ICH biannual Assembly and Management Committee meetings scheduled for May...
SK bioscience Introduces New Global Partnership Model for Vaccines
30/01/2023 - Offers partnership model to transplant vaccine manufacturing facilities, technologies, and products to any countries in need.
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
Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
30/01/2023 - This guidance describes the Food and Drug Administration’s (FDA or the Agency) regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in...
FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems
30/01/2023 - FDA is issuing an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to improve the supply of pediatric ibuprofen amid record high demand.
Stevanato Group, Transcoject Partner on Pre-Fillable Syringe Polymer Options
30/01/2023 - Offering to include COP and COC PFS that can be used in a wide range of applications, including sensitive biologics, mRNA vaccines, hyaluronic acid-based drugs.