FDA: Publications and Resources

Summary: The FDA Drug and Product Approvals publications on Disabled World offer a range of articles and research relevant to medical advancements and safety. These publications include FDA announcements, research papers, and product releases covering topics such as new drug approvals like those for multiple sclerosis or Duchenne muscular dystrophy, medical device clearances such as glucose monitoring systems, and warnings regarding consumer products, like hand sanitizers or weight loss supplements. Many of the articles are peer-reviewed and offer updates, revisions, and insights that can be interesting, helpful, and of use to the general public, including seniors, people with disabilities, and those interested in staying informed about healthcare options and regulatory actions.

Searching the Database: The data table below lists items that may have been updated or revised, but the table defaults to sorting by descending publication date; you can search and sort by clicking column headers (JavaScript required). Items in this category are also distributed via our FDA RSS feed.

FDA: Publications and Resources
Title of Document	Paper Author	Peer Review	Preface / Postface	Reference Number	Publish Date	Updated / Revised
Cognoa ASD Diagnosis Aid Approved for Marketing by FDA	U.S. Food and Drug Administration	Yes		DW-A013977	2021/06/03	2024/05/16
IpsiHand Brain-Computer Stroke Rehabilitation Device FDA Approved	U.S. Food and Drug Administration		✓ Preface ✓ Postface	DW-A013958	2021/04/24	2026/01/15
Safety and Effectiveness of Consumer Hand Sanitizers	U.S. Food and Drug Administration			DW-A013798	2019/04/11	2020/03/21
Generic Version of EpiPen Approved by U.S. FDA	U.S. Food and Drug Administration			DW-A013524	2018/08/19
Scammers Target Consumers with Fake FDA Warning Letters	U.S. Food and Drug Administration			DW-A013494	2018/07/13	2019/04/30
FDA Approves Glucose Monitoring System with Sensor and App for Adults with Diabetes	U.S. Food and Drug Administration (FDA)			DW-A013481	2018/06/21	2019/02/08
Automated Insulin Delivery and Monitoring System for Younger Pediatric Patients Approved by FDA	U.S. Food and Drug Administration (FDA)			DW-A013480	2018/06/21	2019/02/08
US FDA Authorizes First Fully Interoperable Continuous Glucose Monitoring System	U.S. Food and Drug Administration			DW-A013355	2018/03/29
Statement From FDA Commissioner on Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices	U.S. FDA			DW-A013201	2018/01/03	2018/03/15
FDA Permits Marketing of Device to Treat Diabetic Foot Ulcers	U.S. Food and Drug Administration			DW-A013188	2017/12/28	2018/03/15
FDA Approves Kymriah for Cancer and Life-threatening Diseases Treatment	U.S. Food and Drug Administration	Yes	✓ Preface ✓ Postface	DW-A013006	2017/09/22	2025/05/14
U.S. FDA Approves Radicava (Edaravone) to Treat ALS	U.S. Food and Drug Administration			DW-A012832	2017/05/06
U.S. FDA Approves Ocrevus (Ocrelizumab) to Treat Multiple Sclerosis	U.S. Food and Drug Administration (FDA)			DW-A012770	2017/03/30
Researchers Want More Transparency From the US FDA	Johns Hopkins University Bloomberg School of Public Health	Yes		DW-A012754	2017/03/18	2023/09/19
FDA Approves Noctiva for Frequent Night Urination Treatment	U.S. Food and Drug Administration			DW-A012735	2017/03/07
FDA Approves Emflaza (Deflazacort) to Treat Duchenne Muscular Dystrophy	U.S. Food and Drug Administration (FDA)			DW-A012683	2017/02/09
Lawsuit Urges FDA to Protect Hair Salon Workers and Consumers from Formaldehyde	Environmental Working Group			DW-A012558	2016/12/14
FDA Approves First Drug to Treat Duchenne Muscular Dystrophy	U.S. FDA			DW-A012373	2016/09/20
FDA Challenged to Support Claims Regarding Electronic Cigarettes	E-Cigarette Reviewed			DW-A09588	2013/02/20
Ethical Dilemmas Contribute to Weakness in FDA Postmarket Oversight	Johns Hopkins Medicine			DW-A09209	2012/08/23	2021/08/05
Insomnia Drug Intermezzo Approved by FDA	U.S. Food and Drug Administration			DW-A08671	2011/11/25
FDA Approves Cialis for Enlarged Prostate Treatment BPH	U.S. Food and Drug Administration	Yes	✓ Preface ✓ Postface	DW-A08552	2011/10/13	2026/01/19
Boostrix for Tetanus, Diphtheria and Pertussis in Seniors	U.S. Food and Drug Administration			DW-A08164	2011/07/10
FDA Approves Lazanda (Fentanyl) Nasal Spray for Breakthrough Cancer Pain	Archimedes Pharma Ltd.			DW-A08091	2011/06/30
Global Strategy to Help Ensure Safety and Quality of Imported Products	U.S. Food and Drug Administration			DW-A08001	2011/06/20
Injectable Gel to Treat Fecal Incontinence Approved by FDA	U.S. Food and Drug Administration			DW-A07790	2011/05/28
Toxoplasmosis Parasite Infection Test	U.S. Food and Drug Administration			DW-A07745	2011/05/24	2019/01/16
Sutent for Rare Type of Pancreatic Cancer Approved by FDA	U.S. Food and Drug Administration			DW-A07719	2011/05/22
Q Fever Test for Military Serving Overseas	U.S. Food and Drug Administration			DW-A07717	2011/05/22	2022/03/28
Edurant FDA Approved HIV Treatment	U.S. Food and Drug Administration			DW-A07709	2011/05/20	2022/03/29
FDA Approves Victrelis for Hepatitis C	U.S. Food and Drug Administration			DW-A07653	2011/05/14
FDA Approves Tradjenta (linagliptin) for Treatment of Type 2 Diabetes	FDA Approvals			DW-A07557	2011/05/03
Horizant for Restless Legs Syndrome FDA Approved	U.S. Food and Drug Administration			DW-A07403	2011/04/10
FDA Proposes Draft Menu and Vending Machine Labeling Requirements	U.S. Food and Drug Administration			DW-A07360	2011/04/01
Yervoy Ipilimumab Treatment for Late Stage Skin Cancer	U.S. Food and Drug Administration			DW-A07310	2011/03/28	2022/05/02
Zostavax Vaccine to Prevent Shingles - FDA Approval	U.S. Food and Drug Administration			DW-A07291	2011/03/25
FDA Approves Edarbi for High Blood Pressure	U.S. Food and Drug Administration			DW-A07090	2011/02/26	2022/05/22
Neuralstem Receives FDA Orphan Designation for Spinal Cord Stem Cells for Treatment of ALS	Neuralstem, Inc.			DW-A06953	2011/02/14
FDA Approves Viibryd to Treat Major Depressive Disorder	U.S. Food and Drug Administration			DW-A06702	2011/01/22
Natroba (Spinosad) Head Lice Treatment for Children and Adults - FDA Approval	U.S. Food and Drug Administration			DW-A06662	2011/01/18
FDA Warns Consumers Not to Use Fruta Planta Weight Loss Products	FDA			DW-A06542	2011/01/01
Extension of FDA Review for Cladribine Tablets for Treatment of Relapsing Forms of Multiple Sclerosis	EMD Serono, Inc.			DW-A06293	2010/11/26	2017/02/13
FDA Approves Cymbalta for Chronic Musculoskeletal Pain	Eli Lilly and Company			DW-A06115	2010/11/07
FDA Approval of First Drug to Treat Tuberous Sclerosis Complex	Tuberous Sclerosis Alliance			DW-A06039	2010/10/30	2017/06/26
PRADAX Approved for for Stroke Prevention in Canadians with Atrial Fibrillation	BOEHRINGER INGELHEIM			DW-A06003	2010/10/27
New Oral Contraceptive Also Raises Folate Levels	Bayer HealthCare Pharmaceuticals Inc.			DW-A05555	2010/09/25
Oral Drug to Reduce MS Relapses FDA Approved	U.S. Food and Drug Administration			DW-A05499	2010/09/22
FDA Approves Krystexxa for Treatment-Resistant Gout	U.S. Food and Drug Administration	Yes	✓ Preface ✓ Postface	DW-A05372	2010/09/15	2025/05/27
FDA Approves Pediatric Use of Chemical Poisoning Treatment	U.S. Food and Drug Administration			DW-A05288	2010/09/09
Actavis Receives FDA Approval of Atomoxetine HCl Capsules for ADHD	Actavis Inc.			DW-A05187	2010/09/02
FDA Approves Ella Abortion Drug as Emergency Contraceptive	Family Research Council	Yes		DW-A04911	2010/08/15	2024/06/14
Public Outcry for FDA Reform	Ian C. Langtree			DW-A04891	2010/08/13	2022/03/22
FDA Approves Vaccines for 2010-2011 Influenza Season	U.S. Food and Drug Administration			DW-A04787	2010/07/31
New York State Approves Quest Diagnostics Fragile X Syndrome Test	Quest Diagnostics			DW-A04774	2010/07/30
Implantable Miniature Telescope Improves Sight of AMD Patients	U.S. Food and Drug Administration			DW-A04547	2010/07/08
Circadin Approved in EU for Treatment of Primary Insomnia	Neurim Pharmaceuticals LTD			DW-A04529	2010/07/05
FDA Approves New Treatment for Advanced Prostate Cancer	U.S. Food and Drug Administration			DW-A04363	2010/06/18
FDA Clearance of Lactate Test	Epocal, Inc.			DW-A04323	2010/06/15
FDA Advisory Committee Recommends Approval of FTY720 Fingolimod for Relapsing Remitting Multiple Sclerosis	Novartis Pharmaceuticals Corporation			DW-A04301	2010/06/12
FDA to Review Dental Amalgam	U.S. Food and Drug Administration			DW-A04283	2010/06/10
FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women	U.S. Food and Drug Administration			DW-A04156	2010/06/01
LensAR Laser System Receives FDA Clearance for Use in Cataract Surgery	LensAR, Inc.			DW-A03974	2010/05/18
FDA Clearance for Redsense Safety Device for Home use During Home Hemodialysis	Redsense Medical AB			DW-A03972	2010/05/18
Equal Rigor in Assessing Food Claims and Drug Approvals	Institute of Medicine (National Academy of Medicine)	Yes		DW-A03906	2010/05/12	2024/09/03
U.S. FDA Approves Natazia, a New Oral Contraceptive for the Prevention of Pregnancy	Bayer HealthCare Pharmaceuticals Inc.			DW-A03849	2010/05/08
FDA Approves VIMOVO for At-Risk Arthritis Patients	Ian C. Langtree		✓ Preface ✓ Postface	DW-A03785	2010/05/03	2025/06/27
FDA Approval of Asclera to Treat Varicose Veins	Merz Aesthetics			DW-A03686	2010/04/24	2010/05/29
Device Manufacturers to Include Information on Pediatric Populations	U.S. Food and Drug Administration			DW-A03519	2010/03/31
FDA Approval of Differin (adapalene) Lotion for Acne Treatment	Galderma Laboratories, L.P.			DW-A03469	2010/03/22	2010/06/25

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