New Era of Smarter Food Safety
A new approach to food safety that recognizes and builds on the progress made in the past but looks towards what processes and tools will be needed for the future.
Fostering Drug Competition
Increasing the availability of generic drugs helps to create competition in the marketplace, helping make treatment more affordable and increasing access to healthcare for more patients.
Combating the Opioid Crisis
FDA takes actions to combat prescription opioid abuse.
Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution USP 4% Due to Super Potency
Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance
Gilead Issues A Voluntary Nationwide Recall of Two Lots of Veklury® (Remdesivir) Due to Presence of Glass Particulates
FDA Works to Strengthen Food Safety Protections as Consumers Increasingly Order Foods Online
FDA wants food safety measures that are as modern as the food delivery systems themselves.
How CDRH’s Digital Transformation Initiative Will Strengthen the Premarket Review Program
To meet our public health mission, it is critical that FDA continues to evolve to help speed innovations that make medical products safer and more effective.
FDA’s Advanced Manufacturing Initiatives Helping to Provide Quality Human Drugs for Patients
FDA has established numerous initiatives, including the development of a research program to better understand the science of advanced manufacturing.
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry