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1 FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings
2 FDA Approves Oral Treatment for Spinal Muscular Atrophy
3 FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test
4 FDA Finalizes Rule Related to Gluten-Free Labeling for Foods Containing Fermented, Hydrolyzed Ingredients
5 FDA Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging
6 FDA Warns Companies Illegally Selling Hangover Remedies
7 Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools
8 Stephen Hahn, F.D.A. Chief, Is Caught Between Scientists and the President
9 FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products
10 Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products
11 Coronavirus (COVID-19) Update: Daily Roundup August 4, 2020
12 Coronavirus (COVID-19) Update: Daily Roundup August 11, 2020
13 Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing
14 FDA Proposes New Rule on Reporting Requirements
15 Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for Infants
16 FRESHOUSE II, LLC Voluntarily Recalls Select Mesh Bags and Bulk Shipments of Potatoes, Limes, Valencia Oranges and Lemons Because of Possible Health Risk
17 FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL
18 Coronavirus (COVID-19) Update: Daily Roundup August 10, 2020
19 Spokane Produce Inc. Issues Recall of Products Containing Onions Because of Possible Health Risk
20 Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection
21 FDA Protects Patients and Consumers from Fraud During COVID-19
22 FDA Announces New Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water
23 Coronavirus (COVID-19) Update: Daily Roundup August 6, 2020
24 Thomson International Inc. Conducts Voluntary Recall of Red, Yellow, White, and Sweet Yellow Onions Because of Possible Salmonella Risk
25 An Update and Behind the Scenes: FDA's Coronavirus Treatment Acceleration Program
26 Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Ear
27 FDA Notifies Companies, Including Puff Bar, to Remove Flavored Disposable E-Cigarettes and Youth-Appealing E-Liquids from Market for Not Having Required Authorization
28 FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone
29 Coronavirus (COVID-19) Update: Daily Roundup August 5, 2020
30 Eton Pharmaceuticals Provides Update on the FDA Review of EM-100
31 Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce US Food and Drug Administration Acceptance of Biologics License Application (BLA) for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease and Grants Priority Review
32 Why Has The FDA Not Approved Home-Based Coronavirus Testing?
33 Theranexus and BBDF Obtain Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the Food and Drug Administration (FDA) for BBDF-101 for Batten Disease
34 Coronavirus (COVID-19) Update: Daily Roundup August 7, 2020
35 FDA Action Alert: Fennec, Gilead/Kite, Deciphera and Jazz/PharmaMar
36 FDA: Listeria Concerns Lead To Lemon, Lime, Orange And Potato Recall
37 Coronavirus (COVID-19) Update: Daily Roundup July 29, 2020
38 FDA Approves Initiation of IGC's Cannabinoid Trial on Alzheimer's Patients
39 American Gene Technologies gets FDA approval for clinical trial of HIV program
40 FDA authorizes Subsalve Oxygen Treatment Hood for emergency use to treat Covid-19
41 Taylor Farms Issues Recall of Products Containing Onions Because of Possible Health Risk
42 Weekly Sanitizer FDA Recall List
43 Potential HIV cure Phase I trial gets FDA green light
44 Update on Scheduled FDA Advisory Committee Meeting Australian Stock Exchange:MSB.AX
45 FDA, Red Cross urge coronavirus survivors to donate plasma as demand increases
46 The Food and Drug Administration (FDA) Believes The US Won’t Cut Corners Regarding COVID-19 Vaccine
47 Coronavirus (COVID-19) Update: Daily Roundup July 14, 2020
48 Mallinckrodt Announces US Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1)
49 Meet the most important federal official you probably don’t know — the man who holds the fate of the coronavirus vaccine in his hands
50 U.S. Food and Drug Administration Approves Lampit® (nifurtimox) for the Treatment of Chagas Disease in Children
51 FDA Approves TMS Therapy to Treat OCD
52 FDA list of recalled hand sanitizers inflates to nearly 150
53 FDA Authorizes Sequencing-Based COVID-19 Test
54 FDA's Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability
55 FDA Clears Favipiravir for COVID-19 Facility Outbreak Prevention Study
56 Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to The Potential Presence of Undeclared Methanol (Wood Alcohol): Updated August 7, 2020
57 Nation's food, drug officials' association gives FDA blueprint thumbs up
58 Gilead seeks FDA approval for remdesivir
59 FDA approves first oral drug for spinal muscular atrophy
60 FDA Provides Playbook for Developing Cannabis Drugs
61 FDA restricts tramadol use after death of patient
62 FDA approves TMS for obsessive compulsive disorder treatment
63 Biogen's highly-anticipated Alzheimer's drug wins FDA fast-track
64 COVID-19 treatment: Gilead submits New Drug Application to FDA for Remdesivir
65 Ag Needs White House Support on Gene-Edited Livestock Oversight
66 Investing in Advanced Manufacturing to Support Public Health
67 FDA medical device user fees to increase 7% in 2021
68 Coronavirus (COVID-19) Update: Daily Roundup
69 FDA won't 'cut corners' to approve a Covid-19 vaccine, commissioner says
70 Lantheus Holdings, Inc. Announces FDA Approval of VIALMIX® RFID Device for DEFINITY®
71 Mesoblast Plunges as FDA Questions Cell-Therapy Manufacturing
72 Lawmakers urge the FDA to temporarily clear e-cigarettes from market amid Covid pandemic. Here's why
73 Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for PEDMARK™ to Prevent Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors
74 FDA Bans Dozens Of Hand Sanitizers Containing Toxic Ingredients
75 FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer
76 FDA Coronavirus (COVID-19) Update: August 11th, 2020
77 Life Spine Announces FDA 510(k) Clearance for the PLATEAU®-X Ti Lateral Lumbar Spacer System
78 Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry
79 Hemp insiders brace for FDA's CBD enforcement policy
80 Progressive Produce Voluntarily Recalls Red and Yellow Onions Because of Possible Health Risk
81 Former FDA chief Dr. Scott Gottlieb wary of safety of Russia's coronavirus vaccine: 'I wouldn't take it'
82 The Laws And Regulations On Hemp CBD In All 50 States
83 ARCA Biopharma Announces Completion of FDA Pre-IND Consultation Under Coronavirus Treatment Acceleration Program for AB201 as a Potential Treatment for Severe COVID-19
84 Ferring US Issues Voluntary Nationwide Recall of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL Due to Superpotency
85 Former FDA commissioner Scott Gottlieb: Pac-12, Big Ten football could have been played ‘reasonably safely'
86 What Makes Vaccines Safe?
87 Clinical trial focuses on reducing overactive immune response in COVID-19
88 Ocugen Receives Fourth FDA Orphan Drug Designation for the Same Product, OCU400 (AAV-NR2E3) Gene Therapy, for the Treatment of Another Key Inherited Retinal Disease (IRD), PDE6B Gene Mutation-Associated Retinal Diseases
89 FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests
90 New Drug Discovery Process Could Significantly Cut Development Time
91 Akari Therapeutics Announces Successful End-of-Phase II Meeting With FDA to Initiate Pivotal Phase III Study for Treatment of Bullous Pemphigoid With Nomacopan
92 Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
93 FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD
94 Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system
95 FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
96 Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments
97 Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
98 FDA Offers Assurance About Food Safety and Supply During COVID-19
99 Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for 'Off-Label' Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems
100 FDA's Actions in Response to 2019 Novel Coronavirus at Home and Abroad