FDA launches new resource to provide easily accessible, more accurate historical drug approval data
FDA is launching a new resource to assist external and agency researchers collecting historical information about FDA ’s drug approvals. The Compilation of Center for Drug Evaluation and Research (CDER) New Molecular Entity (NME) Drug and New Biologic Approvals is a .CSV file available on the agency’ (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy - 524550 - 04/22/2019
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 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

2020 Meeting Materials, Pulmonary-Allergy Drugs Advisory Committee
Materials for the Pulmonary-Allergy Drugs Advisory Committee meetings for 2020, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, summary minutes, and transcript (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

April 21, 2020: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement - 04/21/2020 - 04/21/2020
April 21, 2020: Meeting of the Pulmonary-Allergy 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 - February 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

2020_02 Test Article EDITED FT 01
2020_02 Test Article some long description some long description. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

La FDA investiga para acelerar la creaci ón de vacunas y terapias contra el virus del Zika
Un nuevo modelo a base de ratones dise ñado por científicos de la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) podría ayudar a explorar la posible actividad de las vacunas y terapias contra el virus del Zika. Publicado hoy en PLoS Pathogens, es la descripción de un modelo a base d e ratones neonatos que proporciona una plataforma para, posiblemente, mejorar y agilizar los estudios que permitan entender las causas y los efectos (la patología) del virus del Zika. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

La FDA concede la aprobaci ón acelerada al primer medicamento para la distrofia muscular de Duchenne
La Administraci ón de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó el día de hoy la inyección Exondys 51 (eteplirsen), el primer medicamento aprobado para tratar a los pacientes que padecen distrofia muscular de Duchenne (DMD). El Exondys 51 está específicamente indic ado para los pacientes que presentan una mutación confirmada del gen de la distrofina responsable de saltarse el exón 51, la cual afecta a alrededor del 13 por ciento de la población con DMD. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Primera vacuna aprobada por la FDA para prevenir la enfermedad meningoc ócica causada por el serogrupo B
La Administraci ón de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de los Estados Unidos anunció hoy la aprobación del Trumenba, la primera vacuna autorizada en los Estados Unidos para prevenir la enfermedad meningocócica invasiva causada por el serogrupo B de la Neisseria meningitidis en personas de entre 10 y 25 años de edad. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Rare Diseases at FDA
The FDA works with many people and groups, such as patients, caregivers, and drug and device manufactures, to support rare disease product development. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 20, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Study Data Technical Conformance Guide - Technical Specifications Document
This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 20, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use
This Points to Consider (PTC) document has been developed for manufacturers of monoclonal antibody products for human use. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 20, 2020 Category: Drugs & Pharmacology Authors: FDA 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

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

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

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

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

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

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

How FDA Plans to Help Consumers Capitalize on Advances in Science
(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

FDA Working to Lift Barriers to Generic Drug Competition
(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

FDA Widens Scope of Navigator – Information Tool for Expanded Access
FDA Widens Scope of Navigator – Information Tool for Expanded Access (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

FDA is Using Innovative Methods to Prevent Illegal Products with Hidden Drug Ingredients from Entering 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 - February 14, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options
(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

FDA Takes Important Steps to Stem the Tide of Opioid Misuse and Abuse
(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

APS BioGroup, Inc - 04/05/2018
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 14, 2020 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

Caution: Some Over-the-Counter Medicines May Affect Your Driving
Antihistamines and other OTC drugs can impair your ability to drive and operate machinery. (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

Benzocaine and Babies: Not a Good Mix
Parents should avoid using benzocaine products to relieve teething pain for children under 2. They are at risk for the disease methemoglobinemia. (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

Data Standards Program Strategic Plan and Board
The Data Standards Strategy reinforces CDER ’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market. (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