Biotecnología
Biotecnología
2018 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee)
30/11/2022 -
This page contains the meeting materials for the Antimicrobial Drugs Advisory Committee meetings for 2017, including the meeting announcement, briefing materials, committee roster, webcast...
2019 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee
30/11/2022 -
This page contains the meeting materials for the Cardiovascular and Renal Drugs Advisory Committee meetings for 2019
Incannex, Eurofins Enter Development & Mfg. Pact for Addiction Disorder Meds
30/11/2022 -
Eurofins will provide formulation development and manufacture of chewable CannQuit Nicotine (CannQuit-N) and CannQuit Opioid (CannQuit-O).
Aptamer Group Opens New State-of-the-Art Facilities
30/11/2022 -
New site will help to expand capacity of Aptamer’s Optimer platform to deliver novel binders for the bioprocessing, diagnostic, and drug development sectors.
FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products - 11/15/2022
30/11/2022 -
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual patient-focused drug development listening meeting to better...
Biosimilar Product Information
30/11/2022 -
This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication...
FDA Roundup: November 29, 2022
30/11/2022 -
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Immutep Enters Clinical Trial Collaboration Merck KGaA and Pfizer
30/11/2022 -
To evaluate new combination study of its first-in-class LAG-3 candidate, eftilagimod alpha, and avelumab to treat urothelial cancer.
Biocon Completes Acquisition of Viatris' Global Biosimilars Business
30/11/2022 -
Creates an integrated, leading global biosimilars enterprise with eight commercialized products.
Andelyn Biosciences to Bring First Gene Therapy for Treatment of INAD to Clinical Trials
30/11/2022 -
Infantile Neuroaxonal Dystrophy (INAD) is a rare inherited neurological disorder.
Avectas Expands Collaboration with CCRM and OmniaBio Inc.
30/11/2022 -
Will enable the development of gene-edited induced pluripotent stem cells using Avectas' non-viral cell engineering platform, SOLUPORE.
Guidance Webinar Series
30/11/2022 -
FDA's Guidance Webinar series aims to foster collaboration and transparency in the development of guidance documents through direct outreach to affected stakeholders.
Information for Practitioners - FDA’s Regulatory Oversight of Regenerative Medicine Products - 11/17/2022
28/11/2022 -
The FDA’s Center for Biologics Evaluation and Research (CBER) is hosting a public webinar on November 17, 2022, at 11:00 am.
Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone, Intradermal Quadrivalent, Fluzone Quadrivalent Southern Hemisphere
28/11/2022 -
For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
MedWatch Forms for FDA Safety Reporting
28/11/2022 -
Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online.
Charging for Investigational Drugs Under an IND - Questions and Answers
24/11/2022 -
Guidance for Industry - Charging for Investigational Drugs Under an IND - Questions and Answers, Procedural
BeSafeRx: Resources for Consumers
24/11/2022 -
Online Pharmacy Risks and Safety Precautions: FDA provides additional information and resources for consumers who are thinking of buying prescription medicine online.
Compounding: Inspections, Recalls, and other Actions
24/11/2022 -
Human drug compounding; FDA inspections; compounding recalls
CBD American Shaman, LLC - 628753 - 11/16/2022
23/11/2022 -
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Anabolic Laboratories Inc - 636308 - 11/14/2022
23/11/2022 -
New Drug/Misbranded
Tainted Sexual Enhancement Products
23/11/2022 -
Sexual enhancement products sold over the counter may contain hidden drugs that could be harmful. Buyers should use caution. There is a growing trend of dietary supplements or conventional foods with...
