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Nieuwsfeed
- Vaccines
- Regulation of the Blood Supply
- Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin Due to Possible Microbial Contamination
- Allergenics
- Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter
- Cellular & Gene Therapy Products
- Golean Detox USA Issues Voluntary Nationwide Recall of Golean DETOX Capsules Due to Presence of Undeclared Sibutramine and Phenolphthalein
- Tissue & Tissue Products
- Is it legal for me to personally import drugs?
- Xenotransplantation
- FDA in Brief: FDA warns company for putting consumers at risk through distribution of non-compliant and misbranded drug ingredients
- Safety & Availability (Biologics)
- Recalls (Biologics)
- Report a Problem to the Center for Biologics Evaluation & Research
- Vaccine Adverse Events
- HIV Home Test Kits
- FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
- FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
- Development & Approval Process (CBER)
- Orthopedic patients eagerly await surgeries delayed by Covid-19; coalition calls for opioid settlement funds to go to evidence-based efforts
- Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER)
- Premarket Approval (PMA) Process (CBER)
- Biologics License Applications (BLA) Process (CBER)
- Professional Compounding Centers of America dba PCCA - 597638 - 01/27/2021
- 5-Minute Survey: Executive Summary for the Guidebook on Understanding FAA Grant Assurance Obligations
- 5-Minute Survey: User Guides for Noise Modeling of Commercial Space Operations—RUMBLE and PCBoom
- As new Covid-19 task force gets underway, threat looms of vaccine, monoclonal antibody-resistant variants
- Roster of the Blood Products Advisory Committee
- New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
- 510(k) Process (CBER)
- Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality
- 5-Minute Survey: Guidebook for Advanced Computerized Maintenance Management System Integration at Airports
- 5-Minute Survey: Guidance for Planning, Design, and Operations of Airport Communications Centers
- Guidance, Compliance & Regulatory Information (Biologics)
- DarioHealth moves into back pain with $31M acquisition
- Last chance: Reserve a spot to explore how to prevent a black market for Covid-19 vaccines
- 5-Minute Survey: Legal Issues Related to Implementation and Operation of SMS for Airports
- 5-Minute Survey: Airport Public Health Preparedness and Response
- Electronic Submissions Presentations
- Leveringsproblemen zetten vaccinatiestrategie nog verder onder druk
- Deskundigen maken gehakt van uitleg De Jonge over GGD-datalek
- 5-Minute Survey: Legal Considerations in the Funding and Development of Intermodal Facilities at Airports
- 5-Minute Survey: Guidebook on Building Airport Workforce Capacity
- 5-Minute Survey: Airport Air Quality Management 101
- EHR vendors, health systems frequently engage in information blocking, study shows
- Recon: Biden administration to order 200M more COVID vaccine doses; AstraZeneca, EU spar over vaccine supplies
- Register Now: Workshop on Flying in the COVID-19 Era
- Update: Newsletter dates for WCLC in 30 seconds
- Ask the Investor: MedCity INVEST offers new opportunities for startup-investor meetings
- Startup banks on immune-system memory to tackle cancer