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Natural Disaster Preparedness and Response (Drugs)
The FDA reminds consumers to have an emergency plan and to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves and their pets during and after severe storms (tornados, hurricanes, blizzards) and other events that can result in power outages, flooding, or road and business closures. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 22, 2017 Category: Drugs & Pharmacology Source Type: news

January 10, 2018: Meeting of the Bone, Reproductive and Urologic 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 - November 20, 2017 Category: Drugs & Pharmacology Source Type: news

CDER Office of Strategic Programs (OSP)
The Office of Strategic Programs (OSP) leads Center-wide strategic and operational planning and analysis. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 17, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes
[FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes (FDA Drug Safety Communication). Based on FDA ’s comprehensive review of new safety information, the agency is requiring updates to the drug labels of all prescription NSAIDs. Widely used to treat pain and fever from many different long- and short-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu, NSAI Ds are available by prescription and OTC. Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib. (Source: FDA Center for Drug Evaluation...
Source: FDA Center for Drug Evaluation and Research - What's New - November 16, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new information. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 15, 2017 Category: Drugs & Pharmacology Source Type: news

Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment Guidance for Industry
Clinical / Antimicrobial (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 6, 2017 Category: Drugs & Pharmacology Source Type: news

Formal Dispute Resolution: Appeals Above the Division Level Guidance for Industy
Procedural (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 3, 2017 Category: Drugs & Pharmacology Source Type: news

CDER Office of Translational Sciences
The Office of Translational Sciences (OTS) oversees CDER research involving human subjects, the CDER Oak Ridge Institute for Science and Education (ORISE) Program, and CDER regulatory science research. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 23, 2017 Category: Drugs & Pharmacology Source Type: news

CDER Office of Strategic Programs
The Office of Strategic Programs (OSP) leads Center-wide strategic and operational planning and analysis. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 23, 2017 Category: Drugs & Pharmacology Source Type: news

Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
Procedural (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 20, 2017 Category: Drugs & Pharmacology Source Type: news

Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
Procedural (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 20, 2017 Category: Drugs & Pharmacology Source Type: news

Medical Imaging Drugs Advisory Committee Charter
The Medical Imaging Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 11, 2017 Category: Drugs & Pharmacology Source Type: news

Format and Content of a REMS Document Guidance for Industry
Drug Safety (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 11, 2017 Category: Drugs & Pharmacology Source Type: news

Nonprescription Drugs Advisory Committee
he Nonprescription Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 10, 2017 Category: Drugs & Pharmacology Source Type: news

Postmarketing Requirements and Commitments: Reports
Added: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability (FY2012) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 6, 2017 Category: Drugs & Pharmacology Source Type: news

November 1, 2017: 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 - October 3, 2017 Category: Drugs & Pharmacology Source Type: news

October 31, 2017: 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 - October 3, 2017 Category: Drugs & Pharmacology Source Type: news

Expanded Access to Investigational Drugs for Treatment Use — Qs & As
Procedural (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 3, 2017 Category: Drugs & Pharmacology Source Type: news

Expanded Access to Investigational Drugs for Treatment Use — Qs & As
Procedural (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 3, 2017 Category: Drugs & Pharmacology Source Type: news

Generic Drug Development
News and Announcements updated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 27, 2017 Category: Drugs & Pharmacology Source Type: news

La FDA insta a tener precauci ó n al denegar medicamentos para la adicci ó n a opioides a pacientes que toman benzodiacepinas o depresores del sistema nervioso central (SNC): el manejo cuidadoso de los medicamentos puede reducir los riesgos
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 26, 2017 Category: Drugs & Pharmacology Source Type: news

La FDA insta a tener precauci ón al denegar medicamentos para la adicción a opioides a pacientes que toman benzodiacepinas o depresores del sistema nervioso central (SNC): el manejo cuidadoso de los medicamentos puede reducir los riesgos
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 26, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease
The Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning
[8-31-2016] A U.S. Food and Drug Administration (FDA) review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 20, 2017 Category: Drugs & Pharmacology Source Type: news

Dermatologic and Ophthalmic Drugs Advisory Committee Roster
This page contains the DODAC roster, which lists the current members and the current number of vacancies for the committee. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 19, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks
Based on our additional review, the U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction usually outweighs these risks. Careful medication management by health care professionals can reduce these risks. We are requiring this information to be added to the buprenorphine and methadone drug labels along with detai...
Source: FDA Center for Drug Evaluation and Research - What's New - September 19, 2017 Category: Drugs & Pharmacology Source Type: news

Q4B Annex 8: Sterility Test General Chapter
International Council on Harmonisation - Quality (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 18, 2017 Category: Drugs & Pharmacology Source Type: news

Q4B Annex 9: Tablet Friability General Chapter
International Council on Harmonisation - Quality (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 18, 2017 Category: Drugs & Pharmacology Source Type: news

Q4B Annex 5: Disintegration Test General Chapter
International Council on Harmonisation - Quality (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 18, 2017 Category: Drugs & Pharmacology Source Type: news

La FDA recomienda separar las dosis de sulfonato de poliestireno s ódico (Kayexalate) para reducir los niveles de potasio, de las de todo otro medicamento oral
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 11, 2017 Category: Drugs & Pharmacology Source Type: news

La FDA recomienda separar las dosis de sulfonato de poliestireno s ó dico (Kayexalate) para reducir los niveles de potasio, de las de todo otro medicamento oral
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 11, 2017 Category: Drugs & Pharmacology Source Type: news

Natural Disaster Preparedness and Response
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 6, 2017 Category: Drugs & Pharmacology Source Type: news

Generic Drugs: Information for Industry
News and Announcements updated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 6, 2017 Category: Drugs & Pharmacology Source Type: news

Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling
Electronic Submissions (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 1, 2017 Category: Drugs & Pharmacology Source Type: news

Safe Drug Use After a Natural Disaster
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 25, 2017 Category: Drugs & Pharmacology Source Type: news

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 7, 2017 Category: Drugs & Pharmacology Source Type: news

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 7, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate)
[03-04-2011] The U.S. Food and Drug Administration (FDA) is informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor
[02-17-2011] The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Liver injury warning to be removed from Letairis (ambrisentan) tablets
The U.S. Food and Drug Administration (FDA) is removing the warning related to liver injury from the boxed warning of the Letairis (ambrisentan) tablet label. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules
[03-29-2011] The U.S. Food and Drug Administration (FDA) is alerting the public to important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone
[05-06-2011] The U.S. Food and Drug Administration (FDA) is alerting the healthcare community about syringe connection problems when certain needleless glass syringes containing the cardiac drugs adenosine and amiodarone are used with particular types of intravenous (IV) access systems. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blockers (ARBs)
[06-02-2011] The U.S. Food and Drug Administration (FDA) has completed a review of the potential risk of cancer associated with the class of medications known as angiotensin receptor blockers (ARBs). FDA has concluded that treatment with an ARB medication does not increase a patient ’s risk of developing cancer. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
[6-9-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Drug labels for the Tumor Necrosis Factor-alpha (TNF & alpha;) blockers now include warnings about infection with Legionella and Listeria bacteria
[9-07-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNF α) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Serious allergic reactions reported with the use of Saphris (asenapine maleate)
[09-01-2011] The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris (asenapine maleate). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication:Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants
[8-03-2011] The U.S. Food and Drug Administration (FDA) is informing the public that chronic, high doses (400-800 mg/day) of the antifungal drug Diflucan (fluconazole) may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer
[07-21-2011] The U.S. Food and Drug Administration (FDA) is continuing to review data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus (esophageal cancer). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 4, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies
[12-14-2011] The U.S. Food and Drug Administration (FDA) is updating the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 3, 2017 Category: Drugs & Pharmacology Source Type: news