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March 23, 2020

On Demand Webinar: Recent Revisions to the ANDA Prioritization MAPP – Jan. 2020

Watch Webinar Now  Download Slides This on-demand webinar is FREE. The FDA offers priority review to abbreviated new drug applications (ANDAs) that may have meaningful impact […]
March 23, 2020

FDA Voices on Medical Products

We use medical products every day. They range from glucose meters and programmable pacemakers, to the pills and products in our medicine cabinets. They include brand […]
March 23, 2020

Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry

Submit Comments by 04/05/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
March 23, 2020

Regulatory Education for Industry (REdI): Generic Drugs Forum April 15 & 16, 2020 – 04/15/2020 – 04/16/2020

On This Page Date: April 15 – 16, 2020 Time: 8:00 AM – 4:00 PM ET Speaker(s): Sally Choe, Ph.D. Leadership Role Director – Office of […]
March 23, 2020

UPDATED INFORMATION: April 21, 2020: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement – 04/21/2020 – 04/21/2020

On This Page Date: April 21, 2020 Time: 8:00 AM – 5:00 PM ET UPDATED INFORMATION (as of 3/23/2020): Due to extenuating circumstances, the Pulmonary-Allergy Drugs […]
March 23, 2020

Drug Trials Snapshots: SARCLISA

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
March 23, 2020

Biosimilar and Interchangeable Biologics: More Treatment Choices

[embedded content] The U.S. Food and Drug Administration (FDA) has approved biosimilar medications to treat conditions such as cancer, Crohn’s disease, colitis, rheumatoid arthritis, psoriasis, and […]
March 22, 2020

Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency

For Immediate Release: March 22, 2020 Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency […]
March 22, 2020

Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals

Docket Number: FDA-2008-D-1106 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research Office of Medical Products and Tobacco, […]
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