CANCELLED March 27, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement
March 27, 2019: 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 - March 11, 2019 Category: Drugs & Pharmacology Source Type: news

Estudio de seguridad revela el riesgo de co águlos de sangre en los pulmones y muerte con una dosis más alta de tofacitinib (Xeljanz, Xeljanz XR) en pacientes con artritis reumatoide; la FDA investigará
Estudio de seguridad revela el riesgo de co águlos de sangre en los pulmones y muerte con una dosis más alta de tofacitinib (Xeljanz, Xeljanz XR) en pacientes con artritis reumatoide; la FDA investigará (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2019 Category: Drugs & Pharmacology Source Type: news

Estudio de seguridad revela el riesgo de co á gulos de sangre en los pulmones y muerte con una dosis m á s alta de tofacitinib (Xeljanz, Xeljanz XR) en pacientes con artritis reumatoide; la FDA investigar á
Estudio de seguridad revela el riesgo de co á gulos de sangre en los pulmones y muerte con una dosis m á s alta de tofacitinib (Xeljanz, Xeljanz XR) en pacientes con artritis reumatoide; la FDA investigar á (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2019 Category: Drugs & Pharmacology Source Type: news

La FDA agrega un Recuadro de advertencia por el aumento en el riesgo de muerte con el medicamento para la gota Uloric (febuxostat)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 1, 2019 Category: Drugs & Pharmacology Source Type: news

Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 25, 2019 Category: Drugs & Pharmacology Source Type: news

FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 21, 2019 Category: Drugs & Pharmacology Source Type: news

March 27, 2019: 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 5, 2019 Category: Drugs & Pharmacology Source Type: news

February 12, 2019: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee
February 12, 2019: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 31, 2019 Category: Drugs & Pharmacology Source Type: news

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee
February 12, 2019: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 30, 2019 Category: Drugs & Pharmacology Source Type: news

FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 21, 2018 Category: Drugs & Pharmacology Source Type: news

Non-Inferiority Clinical Trials
Clinical / Medical; Biostatistics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 13, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte que los s í ntomas de una afecci ó n grave que afecta las c é lulas sangu í neas no son reconocidos con el medicamento para la leucemia Idhifa (enasidenib)
La FDA advierte que los s í ntomas de una afecci ó n grave que afecta las c é lulas sangu í neas no son reconocidos con el medicamento para la leucemia Idhifa (enasidenib) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 7, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte que los s íntomas de una afección grave que afecta las células sanguíneas no son reconocidos con el medicamento para la leucemia Idhifa (enasidenib)
La FDA advierte que los s íntomas de una afección grave que afecta las células sanguíneas no son reconocidos con el medicamento para la leucemia Idhifa (enasidenib) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 7, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte acerca de los riesgos graves de accidente cerebrovascular y desgarro de las paredes de los vasos sangu íneos con el medicamento para la esclerosis múltiple Lemtrada (alemtuzumab)
La FDA advierte acerca de los riesgos graves de accidente cerebrovascular y desgarro de las paredes de los vasos sangu íneos con el medicamento para la esclerosis múltiple Lemtrada (alemtuzumab) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 7, 2018 Category: Drugs & Pharmacology Source Type: news

January 11, 2019: Joint Meeting of the Arthritis 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 - December 3, 2018 Category: Drugs & Pharmacology Source Type: news

January 16, 2019: Meeting of the Bone, Reproductive and Urologic 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 - December 3, 2018 Category: Drugs & Pharmacology Source Type: news

FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 29, 2018 Category: Drugs & Pharmacology Source Type: news

FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 29, 2018 Category: Drugs & Pharmacology Source Type: news

FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 20, 2018 Category: Drugs & Pharmacology Source Type: news

December 17-18, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products 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 24, 2018 Category: Drugs & Pharmacology Source Type: news

UPDATED MEETING TIMES AND PUBLIC PARTICIPATION INFORMATION: October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
October 24-25, 2018: Meeting of the Endocrinologic and Metabolic 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 - October 17, 2018 Category: Drugs & Pharmacology Source Type: news

UPDATED INFORMATION: October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee
October 10, 2018: Meeting of the Oncologic 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 - October 4, 2018 Category: Drugs & Pharmacology Source Type: news

November 1, 2018: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee & Drug Safety and Risk Management Advisory Committee Meeting Announcement
November 1, 2018: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee& 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, 2018 Category: Drugs & Pharmacology Source Type: news

October 24-25, 2018: Meeting of the Endocrinologic and Metabolic 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 19, 2018 Category: Drugs & Pharmacology Source Type: news

October 10, 2018: Meeting of the Oncologic 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 13, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte acerca de casos poco frecuentes de una infecci ó n grave del á rea genital con los inhibidores del SGLT2 para la diabetes
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 7, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte acerca de casos poco frecuentes de una infecci ón grave del área genital con los inhibidores del SGLT2 para la diabetes
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 7, 2018 Category: Drugs & Pharmacology Source Type: news

FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 29, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte acerca del incremento del riesgo de reincidencia del c áncer con el uso del antibiótico azitromicina (Zithromax, Zmax) a largo plazo posterior a un trasplante de células madre de donante
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 8, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte acerca del incremento del riesgo de reincidencia del c á ncer con el uso del antibi ó tico azitromicina (Zithromax, Zmax) a largo plazo posterior a un trasplante de c é lulas madre de donante
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 8, 2018 Category: Drugs & Pharmacology Source Type: news

FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 3, 2018 Category: Drugs & Pharmacology Source Type: news

UPDATED INFORMATION: September 12, 2018: Meeting of the Pharmacy Compounding 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 - July 31, 2018 Category: Drugs & Pharmacology Source Type: news

Stay Informed about Small Business
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 26, 2018 Category: Drugs & Pharmacology Source Type: news

El riesgo de sufrir un trastorno sangu íneo grave y potencialmente mortal insta a la FDA a tomar una medida en cuanto a los productos orales de venta libre a base de benzocaína, utilizados para la dentición y el dolor de boca, y los anestésicos locales recetados
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 31, 2018 Category: Drugs & Pharmacology Source Type: news

El riesgo de sufrir un trastorno sangu í neo grave y potencialmente mortal insta a la FDA a tomar una medida en cuanto a los productos orales de venta libre a base de benzoca í na, utilizados para la dentici ó n y el dolor de boca, y los anest é sicos locales recetados
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 31, 2018 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos La FDA evaluar á el riesgo potencial de defectos cong é nitos del tubo neural ocasionados por el medicamento contra el HIV dolutegravir (Juluca, Tivicay, Triumeq)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 23, 2018 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos La FDA evaluar á el riesgo potencial de defectos congénitos del tubo neural ocasionados por el medicamento contra el HIV dolutegravir (Juluca, Tivicay, Triumeq)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 23, 2018 Category: Drugs & Pharmacology Source Type: news

Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics
FDA is taking safety actions regarding over-the-counter benzocaine oral drug products and prescription local anesthetics. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 22, 2018 Category: Drugs & Pharmacology Source Type: news

Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application
Compliance (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Juluca, Tivicay, Triumeq) used to treat human immunodeficiency virus (HIV). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 18, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte sobre una reacci ón grave del sistema inmunitario con el medicamento para convulsiones y enfermedades psiquiátricas lamotrigina (Lamictal)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 3, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte sobre una reacci ó n grave del sistema inmunitario con el medicamento para convulsiones y enfermedades psiqui á tricas lamotrigina (Lamictal)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 3, 2018 Category: Drugs & Pharmacology Source Type: news

Clinical Trial Imaging Endpoint Process Standards Guidance for Industry
Clinical/Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)
The Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body ’s infection-fighting immune system. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 24, 2018 Category: Drugs & Pharmacology Source Type: news

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
Drug Safety (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 11, 2018 Category: Drugs & Pharmacology Source Type: news

Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling
Advertising (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 26, 2018 Category: Drugs & Pharmacology Source Type: news

Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide)
Over-the-Counter; Small Entity Compliance Guide (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2018 Category: Drugs & Pharmacology Source Type: news

Q8, Q9, & Q10 Questions and Answers -- Appendix: Q & As from Training Sessions (Q8, Q9, & Q10 Points to Consider)
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 - March 22, 2018 Category: Drugs & Pharmacology Source Type: news

S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
International Council on Harmonisation - Safety (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA revisa la descripci ó n de los efectos secundarios para la salud mental de los medicamentos para dejar de fumar Chantix (vareniclina) y Zyban (bupropi ó n) para reflejar las conclusiones de estudio cl í nico
FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 8, 2018 Category: Drugs & Pharmacology Source Type: news