Trump, Biden Face Off Over ACA, COVID in Chaotic First Debate Trump, Biden Face Off Over ACA, COVID in Chaotic First Debate
The President defended his COVID-19 response, saying that he had averted potentially millions of deaths. Biden claimed the president's lack of action cost lives.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - September 30, 2020 Category: Drugs & Pharmacology Tags: Family Medicine/Primary Care News Alert Source Type: news

Consumers may be able to test for Covid-19 with devices they already own, Hopkins finds
A group of Johns Hopkins researchers are developing a new low-cost Covid-19 testing method, drawing inspiration from a device that millions of people already have in their homes. A research team led by Netz Arroyo, assistant professor of pharmacology and molecular sciences, Jamie Spangler, assistant professor of biomedical engineering, and Taekjip Ha, a professor of biophysics and biomedical engineering at Johns Hopkins, is aiming to develop a test for the coronavirus that could be distributed… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 29, 2020 Category: Pharmaceuticals Authors: Morgan Eichensehr Source Type: news

Remarks by Dr. Hahn to the “Advancing Innovative Science in Generic Drug Development” Workshop - 09/29/2020
Remarks by Stephen Hahn, MD COmmissioner of Food and Drugs Sept. 29, 20120 White Oak, MD (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

2020 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

November 6, 2020: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement - 11/06/2020 - 11/06/2020
November 6, 2020: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA) - 11/19/2020 - 11/19/2020
The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Panacea Biotec Limited - 607837 - 09/24/2020
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2020 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

FDA Drug Topics: Labeling Made Simple: The How, What, and Where of Drug Interactions in Prescribing Information – October 27, 2020
FDA ’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Class 3 medicines recall: Theramex Ireland Ltd T/A Theramex HQ UK Ltd, AlfaD capsules
Theramex Ireland Ltd T/A Theramex HQ UK Ltd has informed the Medicines and Healthcare products Regulatory Agency (MHRA) of an issue related to an error in the decommissioning of two batches of AlfaD c (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - September 29, 2020 Category: Drugs & Pharmacology Source Type: news

The Center for Research on Complex Generics
FDA awards a 5-year grant to the University of Maryland and the University of Michigan to establish a Center for Research on Complex Generics (CRCG). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)
Listen to FDA Drug Safety Podcast on Drug Safety Communication titled "FDA warns about serious Problems with high doses of the allergy medicine diphenhydramine (Bendaryl). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class
Listen to an audio podcast of the September 23, 2020, FDA Drug Safety communication to address the serious risks of abuse, addiction, physical dependence, and withdrawal reactions as FDA required the Boxed Warning be updated for all benzodiazepine medicines. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Intrathecal Compounding Specialist, LLC - 610639 - 09/15/2020
Compounding Pharmacy/Adulterated Drug Products (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2020 Category: Drugs & Pharmacology Authors: Division of Pharmaceutical Quality Operations II Source Type: news

BridgeBio Pharma And Affiliate Origin Biosciences Announces FDA Acceptance Of Its New Drug Application For Fosdenopterin For The Treatment Of MoCD Type A
SAN FRANCISCO, September 29, 2020– BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate Origin Biosciences today announced the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for fosdenopterin (previously... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 29, 2020 Category: Drugs & Pharmacology Source Type: news

Statement on Ketamine Sedation and Law Enforcement from the American...
As physicians with expertise in pharmacology and toxicology, we support the appropriate use of ketamine by supervised paramedical professionals for dangerous agitation in the prehospital environment....(PRWeb September 29, 2020)Read the full story at https://www.prweb.com/releases/statement_on_ketamine_sedation_and_law_enforcement_from_the_american_college_of_medical_toxicology/prweb17430581.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - September 29, 2020 Category: Pharmaceuticals Source Type: news

FDA Approves Bausch + Lomb Alaway Preservative Free (Ketotifen Fumarate) Ophthalmic Solution, 0.035%
LAVAL, QC and DEER PARK, Ill., Sept. 25, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ( " Bausch Health " ), Bausch + Lomb, a leading global eye health business, and Eton Pharmaceuticals, Inc. (NASDAQ: ETON) today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 29, 2020 Category: Drugs & Pharmacology Source Type: news

Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act
Guidance for Industry: Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

U.S. FDA Approves Pfizer ’s Xeljanz (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis
NEW YORK--(BUSINESS WIRE) September 28, 2020 -- Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib) for the treatment of children and adolescents 2 years and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 29, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fetroja (cefiderocol) for the Treatment of Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
OSAKA, Japan& FLORHAM PARK, N.J.--(BUSINESS WIRE) September 28, 2020 --Shionogi& Co., Ltd. (hereafter“Shionogi”) today announces that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2020 Category: Drugs & Pharmacology Source Type: news

FDA-NRC Workshop Enhancing Development of Novel Technologies: Radiopharmaceuticals and Radiological Devices - 10/14/2020 - 10/14/2020
Virtual Meeting Workshop (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 28, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

UCLA researchers ’ efforts to combat melanoma gets $13M boost from NIH
UCLA researchers have received a $13 million grant from the National Institutes of Health to find new ways to overcome melanoma resistance to some of the most promising targeted therapies and immunotherapies.There have been significant advancements in the past decade using targeted therapies and immunotherapies for treating people withadvanced forms of this deadliest type of skin cancer, but the treatments still only work in some people. Tumors can — and oftendo— become resistant to these drugs.“While these therapies have transformed the way people with melanoma are treated, only about 40% to 50% of peopl...
Source: UCLA Newsroom: Health Sciences - September 28, 2020 Category: Universities & Medical Training Source Type: news

Hyperbaric Oxygen Therapy for Flares in Ulcerative Colitis Hyperbaric Oxygen Therapy for Flares in Ulcerative Colitis
How effective is hyperbaric oxygen for improving outcomes in hospitalized ulcerative colitis patients with acute moderate-severe flares refractory to standard medical therapy?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 28, 2020 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry
Guidance for Industry (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 28, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk —Questions and Answers
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk —Questions and Answers (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 28, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Qoliana (Brimonidine Tartrate Ophthalmic Solution) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 28, 2020 Category: Drugs & Pharmacology Source Type: news

Alyq (Tadalafil Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 28, 2020 Category: Drugs & Pharmacology Source Type: news

Monoferric (Ferric Derisomaltose Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 28, 2020 Category: Drugs & Pharmacology Source Type: news

Detectnet (Copper Cu 64 dotatate Injection, for Intravenous Use) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 28, 2020 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration Approves Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients
KING OF PRUSSIA, PA – September 28, 2020– CSL Behring, a global biotherapeutics leader, announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Haegarda® (C1 Esterase Inhibitor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2020 Category: Drugs & Pharmacology Source Type: news

Questions Persist About Trump Plan for Drug Discount Cards Questions Persist About Trump Plan for Drug Discount Cards
Administration officials on Friday provided few details about Trump's proposed roughly $6.6 billion initiative, other than saying the proposed Medicare drug discount cards would not reach all eligible people at the same time.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - September 26, 2020 Category: Drugs & Pharmacology Tags: Family Medicine/Primary Care News Source Type: news

Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act
This guidance describes recommended procedures to obtain a National Drug Code (NDC) for certain FDA-approved prescription drug products that are imported into the United States. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 25, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Trump Approves Final Plan to Import Drugs From Canada Trump Approves Final Plan to Import Drugs From Canada
The final plan clears the way for Florida and other states to implement a program bringing medications across the border despite the strong objections of drugmakers and the Canadian government.Kaiser Health News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - September 25, 2020 Category: Drugs & Pharmacology Tags: Internal Medicine News Source Type: news

RPS responds to consultation on medicines regulations
The Government hasconsultedon changes to medicine regulations thesupport the effective rollout of a COVID-19 vaccine and the upscaling of flu vaccination programme in the UK. We asked members for vie (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

Update – Fluoxetine 40mg capsule Serious Shortage Protocol extension
The Department of Health& Social Care (DHSC) has informed us of an extensionto the following Serious Shortage Protocol (SSP). Fluoxetine 40mg capsules The SSP for fluoxetine 40mg capsules is bein (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

Inclusion and diversity agreement with NHS England
We’ve agreed a joint national statement with NHS England and the Association of Pharmacy Technicians UK to improve inclusion, diversity and belonging in pharmacy. Our aim is to work together to (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

Tisseel (Fibrinogen Human, Human Thrombin Kit) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

ArmonAir Digihaler (Fluticasone Propionate Powder for Inhalation) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

What Is Used as Topical Anesthetic?
Title: What Is Used as Topical Anesthetic?Category: MedicationsCreated: 9/25/2020 12:00:00 AMLast Editorial Review: 9/25/2020 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

Why Are Antibiotics Given Before Cutaneous Surgery?
Title: Why Are Antibiotics Given Before Cutaneous Surgery?Category: MedicationsCreated: 9/25/2020 12:00:00 AMLast Editorial Review: 9/25/2020 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

What Does Sedation Feel Like?
Title: What Does Sedation Feel Like?Category: MedicationsCreated: 9/25/2020 12:00:00 AMLast Editorial Review: 9/25/2020 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

Prophylactic Antibiotics for Head and Neck Surgery
Title: Prophylactic Antibiotics for Head and Neck SurgeryCategory: MedicationsCreated: 9/25/2020 12:00:00 AMLast Editorial Review: 9/25/2020 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

What Is the Difference Between Sedation and General Anesthesia?
Title: What Is the Difference Between Sedation and General Anesthesia?Category: MedicationsCreated: 9/25/2020 12:00:00 AMLast Editorial Review: 9/25/2020 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters
WARREN, N.J., Sept. 25, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Nucala (mepolizumab) as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)
London UK 25 September 2020 -- GlaxoSmithKline plc (GSK) today announced the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the treatment of adult and pediatric patients aged 12 years and older with Hypereosinophilic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kalydeco (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age
BOSTON--(BUSINESS WIRE)--Sep. 25, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 25, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Takes Actions to Help Lower U.S. Prescription Drug Prices
Today, HHS and FDA took actions to help provide safe, effective, and more affordable drugs to American patients by completing the rulemaking to allow states to import certain prescription drugs from Canada. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy Medicine
FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

UPDATED TIME, AGENDA, AND MEETING MATERIALS: October 9, 2020: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement - 10/09/2020 - 10/09/2020
October 9, 2020: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

UPDATED TIME AND MEETING MATERIALS INFORMATION: October 8, 2020 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement - 10/08/2020 - 10/08/2020
October 8, 2020 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)
FDA warns against taking higher than recommended doses of over-the-counter Benadryl, which can lead to serious problems and death. We are aware of news reports of teens misusing the drug after participating in “Benadryl Challenge” on TikTok (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 24, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news