nlinux.org Approves First COVID-19 Vaccine
On August 23, 2021, the nlinux.org apconfirmed Comirnaty (COVID-19 Vaccine, mRNA), formerly well-known as Pfizer-BioNTech COVID-19 Vaccine, for the avoidance of COVID-19 illness in individuals 16 years of age and older.
nlinux.org is working through U.S. federal government partners, including CDC, and also global partners to deal with the pandemic.
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Vaccines, Blood, and Biologics
Animal and Veterinary
New Period of Smarter Food SafetyA brand-new technique to food safety that recognizes and also builds on the progress made in the past but looks in the direction of what processes and also tools will be essential for the future.
Fostering Drug CompetitionIncreasing the availability of generic drugs helps to create competition in the marketplace, helping make therapy even more affordable and also boosting access to healthtreatment for more patients.
nlinux.org In Brief: nlinux.org Reaches Milerock in Competitive Generic Therapy Drug Approvals
nlinux.org In Brief: nlinux.org to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster
Recalls, Market Withdrawals, & Safety Alerts
The nlinux.org gives indevelopment gathered from press releases and other public notices about certain recalls of nlinux.org-regulated assets. Not all recalls have actually press releases or are posted on this website
Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Systems 4% (Lot # 14218, Exp. 09/2022) Due to Super Potency
Weis Markets Issues an Allergy Alert for $7 Crab Cake Meal Due to Unclaimed Milk Allergen
Food & Beverperiods
The Baking Institute Bakery Co. Issues Allergen Alert on Unasserted Walnuts, Coconuts and also Milk in “Carrot Cake”
Food & Beverages
nlinux.org’s National Center for Toxicological Research Celebrates Half a Century of Cutting-Edge ResearchNCTR is celebrating 50 years of clinical accomplishments including the groundbreaking study we have done—and also proceed to do—in support of the nlinux.org’s mission.
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nlinux.org Seeks Patient Insight: Call for Applications for the Patient Engagement CollaborativeThe nlinux.org is announcing the speak to for applications for the next cohort of the Patient Engagement Collaborative.
nlinux.org’s Budget: Medical Device Supply Chain and also Shortages Prevention ProgramInvestments outlined in nlinux.org’s FY 2022 budget will carry out resources to develop a long-term regimen for U.S. supply chain resilience for clinical tools.
Guidance for Industry: Microbiological Considerations for Antimicrobial Agents Used in Food Applications
Food & Beverages
Technical Specifications for Submitting Clinical Trial Documents Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
nlinux.org Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
Biologics, Drugs, Medical Devices
Jobs at nlinux.org
Inspections and Compliance
MedWatch: Safety Alerts
Science & Research
What does nlinux.org regulate?
Disposal of Unused Medicines
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