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1 Monkeypox Vaccines: California and FDA Do Not Agree on How to Stretch Meager Supply KQED 2 days ago
2 FDA Recognizes National Immunization Awareness Month WBIW.com 3 days ago
3 Audio Interview: Covid-19 Vaccines and the FDA | NEJM nejm.org 25 days ago
4 Analysis | At Last, a Simple Strategy for Covid Booster Shots The Washington Post 6 days ago
5 Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted FDA.gov 26 days ago
6 FDA explains the ins and outs of real-time oncology review program in new guidance Regulatory Focus 13 days ago
7 Top FDA Officials Concerned About Pressure to Authorize COVID-19 Vaccine Boosters: Emails The Epoch Times 9 days ago
8 FDA's Regulatory Framework for 3D Printing of Medical Devices at the Point of Care Needs More Clarity The Pew Charitable Trusts 12 days ago
9 FDA Seeks Comment On Fit-For-Purpose COAs Guidance Clinical Leader 25 days ago
10 Novavax's U.S. COVID-19 vaccine authorization has arrived FiercePharma 26 days ago
11 How to See August's Perseids Meteor Shower: One of the Year's Best Light Shows KQED 2 days ago
12 Senate Budget Draft Would Be Less Generous To US FDA Than House For FY 2023 Pink Sheet 6 days ago
13 Real-Time Oncology Review (RTOR) Draft Guidance for Industry July 2022 FDA.gov 17 days ago
14 The Critical Role of Patients in Advancing Gene Therapy Treatments FDA.gov 5 months ago
15 Vaccines, Blood & Biologics FDA.gov 3 years ago
16 AstraZeneca, Daiichi Sankyo win FDA label expansion for Enhertu (NASDAQ:AZN) Seeking Alpha 2 days ago
17 FDA Roundup: May 31, 2022 FDA.gov 2 months ago
18 CBER to industry: Normal operations will resume in 2023 Endpoints News 2 months ago
19 US FDA seeks to slash animal testing Chemical & Engineering News 5 days ago
20 Coronavirus (COVID-19) Update: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age FDA.gov 6 months ago
21 Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies FDA.gov 2 months ago
22 Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses FDA.gov 1 month ago
23 CBER's Peter Marks On Complex Biologics Manufacturing Advances BioProcess Online 1 month ago
24 Human Gene Therapy Products Incorporating Human Genome Editing FDA.gov 5 months ago
25 FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Bi FDA.gov 6 months ago
26 Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act FDA.gov 6 months ago
27 Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters FDA.gov 5 months ago
28 FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children FDA.gov 10 months ago
29 FDA Roundup: May 20, 2022 FDA.gov 3 months ago
30 Regulatory Education for Industry (REdI) Annual Conference 2022 FDA.gov 2 months ago
31 Considerations for the Development of (CAR) T Cell Products FDA.gov 5 months ago
32 Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements FDA.gov 3 months ago
33 Manufacture of Blood Components Using a Pathogen Reduction Device FDA.gov 9 months ago
34 Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 Vaccine FDA.gov 6 months ago
35 FDA advisory group to assess future responses to COVID-19 BioPharma-Reporter.com 4 months ago
36 CBER Reorganization Aims To Fight Recruitment Challenges, Tackle Upcoming Gene Therapy Wave Pink Sheet 7 months ago
37 Vaccines and Related Biological Products Advisory Committee March 3, 2022 Meeting Announcement 03/03/2022 6 months ago
38 FDA's Peter Marks on Covid-19, priorities, and gene, cell therapy reviews STAT 7 months ago
39 FDA Vaccine Head Wants Warp Speed Meetings for Lifesaving Drugs Bloomberg Law 3 months ago
40 Vaccines and Related Biological Products Advisory Committee June 28, 2022 Meeting Announcement 06/28/2022 6 days ago
41 FDA Delays Action on Pfizer Vaccine for Kids Under 5 WebMD 6 months ago
42 Congress Presses FDA on Key Policies and Operations Applied Clinical Trials Online 3 months ago
43 FDA sets limits on the use of the Janssen COVID-19 vaccine in US BioPharma-Reporter.com 3 months ago
44 FDA Will Follow The Science On COVID-19 Vaccines For Young Children FDA.gov 11 months ago
45 COVID Didn’t Seem to Slow Down FDA Drug Approvals Policy & Medicine 3 months ago
46 Following Briefing, Clyburn Vows to Hold FDA to Its Commitment to Review Coronavirus Vaccines for Young Children as Expeditiously as Science Allows House Select Subcommittee on the Coronavirus Crisis | 3 months ago
47 FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting FDA.gov 2 years ago
48 FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years the City of Cambridge 3 months ago
49 FDA Officials call COVID-19 the 'New Normal' in Op-Ed BioSpace 3 months ago
50 Vaccines for young kids could be available in June, FDA official says The Washington Post 3 months ago
51 Amneal Appoints Deborah M. Autor to Board of Directors Yahoo Finance 4 days ago
52 This Week at FDA: User fee moves, COVID vaccine updates, and more Regulatory Focus 2 months ago
53 Vaccines and Related Biological Products Advisory Committee April 6, 2022 Meeting Announcement 04/06/2022 3 months ago
54 FDA authorizes Moderna, Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age Contemporary Pediatrics 2 months ago
55 Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals FDA.gov 4 months ago
56 Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds FDA.gov 8 months ago
57 News Scan for Jun 30, 2022 CIDRAP 1 month ago
58 In Brief: FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines | FDA FDA.gov 1 year ago
59 FDA panel backs Moderna’s COVID-19 vaccine for youngest kids Fortune 2 months ago
60 Statement from Peter Marks, M.D., Ph.D., director of FDA's Center for Biologics Evaluation and Research, on FDA's continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine FDA.gov 3 years ago
61 Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters FDA.gov 9 months ago
62 FDA Looks to Improve Cell, Gene Therapy Advice to Drugmakers Bloomberg Law 2 months ago
63 FDA approved more first-in-class drugs, gave more accelerated approvals in 2021 Regulatory Focus 7 months ago
64 Medical Researchers Pen Letter to FDA on T-Cell Significance Contagionlive.com 4 months ago
65 This Week at FDA: Spring regulatory agenda, upcoming guidances, and more Regulatory Focus 1 month ago
66 Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months FDA.gov 7 months ago
67 Coronavirus (COVID-19) Update: October 1, 2021 FDA.gov 10 months ago
68 Benefit-Risk Assessment for New Drug and Biological Products FDA.gov 10 months ago
69 Two top vaccine regulators to leave U.S. FDA Reuters 11 months ago
70 Advancing the Development of Safe and Effective Regenerative Medicine Products FDA.gov 1 year ago
71 CBER sets strategic priorities through 2025 | RAPS Regulatory Focus 1 year ago
72 FDA advisers debate the future booster strategy against coronavirus The Washington Post 4 months ago
73 Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA's Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., cautioning consumers against receiving young donor plasma infusions that are promoted as unproven t FDA.gov 3 years ago
74 CDER Conversation: Information Visualization Platform (InfoViP): CDER’s New Artificial Intelligence Safety Surveillance Tool FDA.gov 1 month ago
75 Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies FDA.gov 4 years ago
76 Unapproved stem cell therapies remains a top FDA enforcement priority JD Supra 2 months ago
77 Development and Licensure of Vaccines to Prevent COVID-19 FDA.gov 2 years ago
78 COVID-19: FDA advisory group plans future strategies Medical News Today 4 months ago
79 Coronavirus (COVID-19) Update: October 29, 2021 FDA.gov 9 months ago
80 FDA Issues Draft Guidance On Human Gene Therapy Products Incorporating Human Genome Editing JD Supra 4 months ago
81 FDA Biosimilar Approval Recap – 2021 | McDonnell Boehnen Hulbert & Berghoff LLP JDSupra 7 months ago
82 Public Meeting Medical Device User Fee Amendments for FY 23-27 4 months ago
83 Review of FDA’s 2021 Drug Approvals – Small Molecules Dominate JD Supra 7 months ago
84 FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases FDA.gov 9 months ago
85 CDER Conversation: CDER Creates New Biosimilars Resources for Educators, Teaching Facilities FDA.gov 8 months ago
86 In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster | FDA FDA.gov 11 months ago
87 Pfizer reports strong COVID vaccine protection in kids under 5, will file with FDA CIDRAP 3 months ago
88 Biologics Products & Establishments FDA.gov 8 months ago
89 FDA Workforce: Agency-Wide Workforce Planning Needed to Ensure Medical Product Staff Meet Current and Future Needs Government Accountability Office 7 months ago
90 FDA's Advanced Manufacturing Initiatives Helping to Provide Quality Human Drugs for Patients FDA.gov 10 months ago
91 Greenleaf Health Announces: Mark Kramer – Former Director of the FDA’s Office of Combination Products – Joins Greenleaf Yahoo Finance 3 months ago
92 FDA issues draft guidance on patient-focused drug development The Cancer Letter 1 month ago
93 Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics 01/27/2022 6 months ago
94 FDA explains plans to bolster cell and gene therapy approvals through wider messaging Regulatory Focus 3 months ago
95 Celiac disease: FDA offers guidance on drug development Regulatory Focus 4 months ago
96 FDA advisers to meet to discuss COVID-19 shots for kids, vaccines for fall ABC News 3 months ago
97 Omicron-Specific COVID Boosters Are Coming Scientific American 1 month ago
98 Robert Califf FDA.gov 6 months ago
99 Data Standards for Drug and Biological Product Submissions Containing FDA.gov 10 months ago
100 FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials FDA.gov 4 months ago