Experts fear false rumours could harm Chinese cooperation on coronavirus
World-leading specialists offer support to Chinese scientists amid ‘crackpot’ theories that virus was manufactured in a labCoronavirus – latest newsWorld-leading experts on the novel coronavirus have signed a statement of support for their Chinese colleagues, who are being attacked on social media and even threatened with violence as false rumours circulate about its origins.There is a real risk that the open and transparent relationship between the Chinese scientists and their western counterparts will come to an abrupt end, impeding the sharing of data and the hunt for treatments and vaccines against Co...
Source: Guardian Unlimited Science - February 20, 2020 Category: Science Authors: Sarah Boseley Health editor Tags: Coronavirus outbreak Infectious diseases Microbiology Medical research Science World news Pharmacy and pharmacology Source Type: news

Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain
SAN DIEGO, Feb. 19, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 19, 2020 Category: Drugs & Pharmacology Source Type: news

' Striking Paradox' of Misaligned Diabetes Treatment Could Harm'Striking Paradox' of Misaligned Diabetes Treatment Could Harm
"The paradox and misalignment of treatment intensity with patients'needs is really striking," says the lead author of a national study of adults with type 2 diabetes.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - February 19, 2020 Category: Drugs & Pharmacology Tags: Diabetes & Endocrinology News Source Type: news

Recommendations for the Submission of LOINC ® Codes in Regulatory Applications to the U.S. Food and Drug Administration
Recommendations for the Submission of LOINC ® Codes in Regulatory Applications to the U.S. Food and Drug Administration (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 19, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act for the electronic format of the content submitted in NDsAs, ANDA, certain BLAs, and certain INDs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 19, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market
Listen to an audio podcast of the February 13 2020 FDA Drug Safety Communicationrequesting the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. Potential risk of cancer outweighs the benefits. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 19, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Serving Public Health Paramount in a Successful 2019 for FDA ’s Generic Drug Program
Our 2019 numbers marked another successful year for the FDA ’s generic drug program and resulted in more treatment choices and greater access to affordable medicines for patients and consumers with a wide range of medical conditions (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 19, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Providing Regulatory Submissions in Electronic Format -- Standardized Study Data
Electronic Submissions (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 19, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments
This document provides current specifications for submitting individual case safety reports (ICSRs) and ICSR attachments in electronic form. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 19, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

eCTD TECHNICAL CONFORMANCE GUIDE
This Document is incorporated by reference into the following Guidance Document(s): Guidance for Industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 19, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry
Pharmacology / Toxicology (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 19, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Best Bentonite - 494502 - 11/23/2018
Unapproved New Drugs/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 19, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Jessie Commodity Co., Ltd. - 576935 - 05/20/2019
Failure to Comply with Drug Listing Requirements/Misbranded, Jessie Commodity Co., Ltd. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 19, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Pizensy (Lactitol Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 19, 2020 Category: Drugs & Pharmacology Source Type: news

Diclostream (Diclofenac Sodium 1.5% Solution and Menthol 10% Topical Liquid) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 19, 2020 Category: Drugs & Pharmacology Source Type: news

Chromium (Chromium Chloride Injection Solution) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 19, 2020 Category: Drugs & Pharmacology Source Type: news

HCV Eradication With DAAs Reduces Variceal Bleeding Risk HCV Eradication With DAAs Reduces Variceal Bleeding Risk
This study found that DAA-induced SVR in patients with hepatitis C is associated with a reduced risk of variceal bleeding, among both patients with and without established cirrhosis.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 19, 2020 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Eton Pharmaceuticals Provides Update on ET-105 Program
DEER PARK, Ill., Feb. 19, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today provided an update on its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 19, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Accepts BioCryst ’s NDA for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks
RESEARCH TRIANGLE PARK, N.C., Feb. 18, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the U.S. Food and Drug Administration (FDA) has accepted and filed its new drug application (NDA) for the approval... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 18, 2020 Category: Drugs & Pharmacology Source Type: news

Horizon Therapeutics plc Announces U.S. FDA Approval of New Dosage Form for Procysbi (Cysteamine Bitartrate) Delayed-Release Oral Granules
DUBLIN--(BUSINESS WIRE)--February 18, 2020 -- Horizon Therapeutics plc (Nasdaq: HZNP) announced today that the U.S. Food and Drug Administration (FDA) has approved Procysbi® (cysteamine bitartrate) delayed-release oral granules in packets for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 18, 2020 Category: Drugs & Pharmacology Source Type: news

Fighting Diabetes' Deadly Impact on Minorities
The Office of Minority Health (OMH) at the Food and Drug Administration (FDA) is working on several fronts to help ethnic and racial minority groups stay healthy and, when appropriate, is helping to raise awareness of available treatments for diabetes. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Taking New Steps to Meet the Challenges of Rare Diseases — FDA Marks the 11th Rare Disease Day
Taking New Steps to Meet the Challenges of Rare Diseases — FDA Marks the 11th Rare Disease Day (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Spring Unified Agenda: FDA ’s Anticipated Upcoming Regulatory Work
Spring Unified Agenda: FDA ’s Anticipated Upcoming Regulatory Work (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Reducing the Hurdles for Complex Generic Drug Development
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

PEPFAR: FDA Approves 200th HIV/AIDS Therapy
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

New Steps To Strengthen FDA ’s Inspection And Oversight Of Drug Manufacturing
New Steps To Strengthen FDA ’s Inspection And Oversight Of Drug Manufacturing (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

La FDA refuerza la advertencia de que el estre ñimiento no tratado causado por el medicamento para tratar la esquizofrenia clozapina (Clozaril) puede provocar graves problemas intestinales
La FDA refuerza la advertencia de que el estre ñimiento no tratado causado por el medicamento para tratar la esquizofrenia clozapina (Clozaril) puede provocar graves problemas intestinales (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

NHS Staff Survey 2019 now published
Commenting on the publication of the NHS Staff Survey 2019, RPS President Sandra Gidley said:“The scale of the challenge to support NHS staff is substantial but it’s heartening to see th (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - February 18, 2020 Category: Drugs & Pharmacology Source Type: news

JBS Souderton, Inc. dba MOPAC - 574386 - 11/18/2019
CGMP/Food for Animals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Celloxess LLC - 495253 - 02/11/2020
New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CPG Sec. 150.500 Analytical Methodology Used by FDA - Drugs
Where FDA sample analysis is a basis for regulatory action only the following procedures are considered appropriate, unless specific instructions to the contrary are given by Center for Drug Evaluation and Research. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Briefing: Primary care providers and the coronavirus (COVID-19)
NHS England and NHS Improvement has issued a briefing note on Coronavirus for the primary care sector. This includes advice to patient and the public and advice for primary care providers such as GP p (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - February 18, 2020 Category: Drugs & Pharmacology Source Type: news

CPG Sec. 160.100 Regulatory Actions and Small Business
FDA will continue to assist firms attempting to bring themselves into compliance. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CPG Sec.140.500 Metric Declarations of Quantity of Contents on Product Labels
This guide establishes general and specific guidance for the voluntary use of metric units of quantity to state the net quantity of contents on the labeling, including the principal display panel, of an FDA-regulated commodity. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CPG Sec 120.500 Health Fraud - Factors in Considering Regulatory Action
Health Fraud products are articles of unproven effectiveness that are promoted to improve health, well being, or appearance. They can be drugs, devices, foods or cosmetics for human or animal use. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CPG Sec 110.900 Imported Products - Lack of English Labeling
Violative imported products should preferably be handled at the port of entry. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CPG Sec 100.900 International Memoranda of Understanding
This guide sets forth policy for initiating, developing, and monitoring agreements such as memoranda of understanding (MOU's) between the Food and Drug Administration (FDA) and foreign governments. The general principles herein may also be applicable to MOU's with international organizations. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CPG Sec 100.600 Status of Facial Tissues, Paper Napkins, Paper Towels and Similar Paper Products
The Food and Drug Administration does not consider facial tissues, paper napkins, paper towels or similar products subject to the Act when sold only for conventional wiping purposes. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CPG Sec 100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients
This policy guide sets forth the position of FDA with respect to products composed of ingredients which were shipped in interstate commerce and were then used in the manufacture of a finished product. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Zerviate (Cetirizine Ophthalmic Solution) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 18, 2020 Category: Drugs & Pharmacology Source Type: news

Perseris (Risperidone) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 18, 2020 Category: Drugs & Pharmacology Source Type: news

Corphedra Injection (Corphedra) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 18, 2020 Category: Drugs & Pharmacology Source Type: news

Speakers announced for 2020 Experimental Biology meeting
(Experimental Biology) Renowned scientists including Nobel laureates, research pioneers and celebrated educators will convene at the Experimental Biology (EB) 2020 meeting, to be held April 4-7 in San Diego. Bringing together more than 12,000 life scientists in one interdisciplinary community, EB showcases the latest advances in anatomy, biochemistry, molecular biology, investigative pathology, pharmacology and physiology. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - February 18, 2020 Category: Cancer & Oncology Source Type: news

PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer
MADRID and DUBLIN, Feb. 17, 2020 /PRNewswire/ -- PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announce that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 17, 2020 Category: Drugs & Pharmacology Source Type: news

Management of dementia-related psychosis, agitation and aggression: a review of the pharmacology and clinical effects of potential drug candidates - Marcinkowska M, Śniecikowska J, Fajkis N, Paśko P, Franczyk W, Kołaczkowski M.
Along with cognitive decline, 90% of patients with dementia experience behavioral and psychological symptoms of dementia, such as psychosis, aggression, agitation, and depression. Atypical antipsychotics are commonly prescribed off-label to manage certain ... (Source: SafetyLit)
Source: SafetyLit - February 17, 2020 Category: International Medicine & Public Health Tags: Age: Elder Adults Source Type: news

Class 4 medicines defect information: Diamorphine hydrochloride BP 100 mg lyophilisate for solution for injection
Accord Healthcare Ltd has advised of an issue related to the expiry date for two batches of diamorphine hydrochloride BP 100 mg lyophilisate for solution for injection, which has not been encoded in 2 (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - February 17, 2020 Category: Drugs & Pharmacology Source Type: news

VOCs in Breath as a Biomarker for Adenomas, Colorectal Cancer VOCs in Breath as a Biomarker for Adenomas, Colorectal Cancer
Might exhaled volatile organic compounds potentially serve as non-invasive biomarkers for the detection of colorectal cancer and its precursor lesions?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 17, 2020 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

RPS welcomes NICE consultation on community pharmacy
We have welcomed a consultation from the National Institute for Health and Care Excellence (NICE) on a quality standard for Community pharmacies: promoting health and wellbeing. The guidelines highli (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - February 17, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves GSK ’s Voltaren Arthritis Pain for Over-the-Counter Use in the United States
Warren, New Jersey, USA  -- February 17, 2020 -- GlaxoSmithKline (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)- arthritis... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 17, 2020 Category: Drugs & Pharmacology Source Type: news

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers
Guidance for Industry - Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – 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 - February 14, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news