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

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

Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use
The FDA is requiring the Boxed Warning be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions across all the medicines in the class. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 23, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Benzodiazepine Drug Information
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 23, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class
Includes warnings about the risks of abuse, addiction, dependence, and withdrawal. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 23, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of RIOMET ER ™ (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER ™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. The reason for the recall is due to (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 23, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

It Just Got Easier for Physicians to Help Their Patients Gain Access to Investigational Treatments
Expanded access helps those patients who do not qualify for a clinical trial or otherwise cannot participate to gain access to investigational treatments. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 23, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Information by Drug Class
FDA provides consumers and industry with safety, regulatory and availability information for various drugs by drug class. From A to Z. Topics include: acetaminophen, estrogen, insulin, opioids, statins, and weight-loss drugs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 22, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

HNC Products Inc. - 607359 - 09/10/2020
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 22, 2020 Category: Drugs & Pharmacology Authors: Division of Pharmaceutical Quality Operations III Source Type: news

Integrated Health Concepts Inc. dba Conversio Health - 610546 - 09/10/2020
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 22, 2020 Category: Drugs & Pharmacology Authors: Division of Pharmaceutical Quality Operations IV Source Type: news

Coupler Enterprises - 607662 - 09/15/2020
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 22, 2020 Category: Drugs & Pharmacology Authors: Division of Pharmaceutical Quality Operations I Source Type: news

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy - 610384 - 09/08/2020
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 22, 2020 Category: Drugs & Pharmacology Authors: Division of Pharmaceutical Quality Operations IV Source Type: news

FDA Alerts of Perrigo's voluntary albuterol inhaler recall
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Remarks by Commissioner Hahn to the Compounding Quality Center of Excellence Conference - 09/21/2020
Remarks by Stephen Hahn, M.D., Commissioner of Food and Drugs, to the Compounding Quality Center of Excellence Conference, Sept. 21, 2020, 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 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

BeSafeRx: Resources for Health Professionals
FDA has created a suite of downloadable materials to help health care professionals educate and support patients who may be using or considering an online pharmacy for buying medicine. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

BeSafeRx: Frequently Asked Questions (FAQs)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Considering an Online Pharmacy?
Consumers may turn to online pharmacies because of convenience, privacy and cost savings; however, some websites sell medicines that are dangerous or even deadly. Protect your health by recognizing the signs of safe and unsafe online pharmacies. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Locate a State-Licensed Online Pharmacy
Checking a pharmacy ’s license through your state board of pharmacy is an important step in knowing whether you are using a safe online pharmacy. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

BeSafeRx: Resources for Consumers
Online Pharmacy Risks and Safety Precautions: FDA provides additional information and resources for consumers who are thinking of buying prescription medicine online. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

BeSafeRx: Resources for the Media
FDA has developed a suite of promotional materials including fact sheets, digital toolkits and videos to educate consumers and health care professionals about the dangers of buying medicines from unsafe websites that look like pharmacies. See Resources for Health Professionals for more information. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid ®, Thyroid Tablets, USP Due to Sub Potency
Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid ®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Scientific Computing Days Posters
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

What's New in Regulatory Science
A newsletter on regulatory science for CDER's stakeholders (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 16, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance
Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 16, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book - 10/27/2020 - 10/28/2020
Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 16, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coping With Memory Loss
A look at various causes of memory loss and treatment approaches. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 15, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 15, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment - 10/15/2020 - 10/16/2020
New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 15, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

La Vita Compounding Pharmacy, LLC - 575286 - 02/28/2019
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 15, 2020 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

Sprout Pharmaceuticals, Inc - 610569 - 08/31/2020
False& Misleading Claims/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 15, 2020 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

Mayon's Pharmaceuticals Pvt Ltd - 607388 - 09/04/2020
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 15, 2020 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

Kalchem International, Inc. - 607098 - 08/27/2020
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 15, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry
Geriatric Information in Human Prescription Drug and Biological Product Labeling (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 15, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 14, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Centurion Labs Issues Voluntary Nationwide Recall of Ninjacof (Lot # 200N1601) and Ninjacof A (Lot# 201NA1601) Products Due to Potential Burkholderia Cepacia Contamination
Centurion Labs is voluntarily recalling, as a precautionary measure, 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 14, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Patient Engagement Opportunities
A description of some the opportunities for patients, caregivers and advocates to engage wit the FDA. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 11, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Learn About FDA Patient Engagement
Learn about the different ways that patients and caregivers are working with the FDA to have their voice included in medical product approvals and FDA policy. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 11, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Patient Engagement Partnerships
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 11, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Patient Engagement Overview*
FDA Patient Engagement Overview (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 11, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels
Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found the M Hand Sanitizer to contain methanol and be sub-potent for ethanol. Substantial methanol exposure can result in nausea, vomiting, headache, blurred v (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 10, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 10, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Medication-house.com - 607751 - 09/02/2020
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 10, 2020 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

Extrapharma.com - 607931 - 09/02/2020
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 10, 2020 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

Efficacy Supplement Approvals
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 10, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA clarifies compounding policies
FDA has received questions and feedback on several of its current policies and is providing the following information to stakeholders to clarify its current thinking. FDA is reviewing the complex issues raised in these comments and taking them into consideration as the agency works to update, revise (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 10, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news