FDA

Cipher Pharmaceuticals Inc. - 11/30/2017

False & Misleading Claims/Misbranded

fda.gov

Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc. - 04/24/2019

False & Misleading Claims/Misbranded

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Avanthi, Inc. - 09/28/2018

False & Misleading Claims/Misbranded

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Trinity Natural Health & Pain Management, Inc. - 614007 - 04/13/2021

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry

fda.gov

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer

FDA granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial cancer who ...

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Topical Dermatologic Corticosteroids: in Vivo Bioequivalence

Biopharmaceutics

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La FDA advierte que el abuso y el uso indebido del descongestionante nasal propilhexedrina causan graves daños

La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de EE. UU. advierte que el abuso y el uso indebido del descongestionante nasal ...

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Coronavirus (COVID-19) Update: April 13, 2021

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FDA D.I.S.C.O. Burst Edition: FDA approval of Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy

Listen to a soundcast of the March 31, 2021 FDA approval of Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone for treatment of adult ...

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Mifeprex (mifepristone) Information

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MYM Hidrominerales S.A. de C.V. - 610066 - 04/09/2021

Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

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Proquimes S A Productos Quimicos Especializados S.A. - 610069 - 04/05/2021

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

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Roque Plast S.A. de C.V. - 609492 - 04/09/2021

Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

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Maison Terre, LLC - 610315 - 04/01/2021

Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

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FDA Study Data Technical Rejection Criteria (TRC): What you need to know! - 05/21/2021 - 05/21/2021

FDA is planning to implement eCTD validations in 2021 specific to submissions containing study data. FDA published the TRC to assist industry in understanding ...

fda.gov

MedWatch Forms for FDA Safety Reporting

Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety ...

fda.gov

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, ...

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NS NY Distributor Inc Issues Voluntary Nationwide Recall of Premium OrgaZen 7000 and Ginseng Power 5000 Due to Presence of Undeclared Sildenafil and/or Tadalafil

NS NY Distributor Inc is voluntarily recalling all lots within expiry of Premium Orgazen 7000 and Ginseng Power 5000 capsules to the consumer level. FDA ...

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DDT COA #000116: PROMIS Itch Questionnaire – Children Impact (PIQ-C-Impact)

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DDT COA #000140: PROMIS Itch Questionnaire – Children Symptom (PIQ-C-Symptom)

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FDA D.I.S.C.O. Burst Edition: FDA approval of ABECMA (idecabtagene vicleucel) the first FDA approved cell-based gene therapy for the treatment of adult patients with relapsed or refractory multiple myeloma

Listen to a soundcast of the March 26, 2021 FDA approval of ABECMA (idacabtagene vicleucel) the first cell-based gene therapy for treatment of adult patients ...

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FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma

FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with ...

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Remarks by Dr. Janet Woodcock to the 2021 Rx Drug Abuse and Heroin Summit - 04/08/2021

Remarks by Dr. Janet Woodcock, Acting Commissioner of Food and Drugs, 2021 Rx Drug Abuse and Heroin Summit, April 8, 2021

fda.gov

FDA D.I.S.C.O. Burst Edition: FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies

Listen to a soundcast of the March 10, 2021 FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma ...

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FDA D.I.S.C.O. Burst Edition: Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

Listen to a soundcast of the March 5, 2021 FDA approval of Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular ...

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FDA D.I.S.C.O. Burst Edition: Lorbrena (lorlatinib) for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, detected by an FDA-approved test

Listen to a soundcast of the March 3, 2021 approval of Lorbrena (lorlatinib) for patients with metastatic non-small cell lung cancer whose tumors are ...

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FDA D.I.S.C.O. Burst: Approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four lines of prior therapy

Listen to a soundcast of the February 26, 2021 FDA approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adults patients with ...

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FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expre

Listen to a soundcast of the February 22nd 2021 FDA approval of Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally ...

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Los resultados iniciales de un ensayo de seguridad revela un mayor riesgo de padecer problemas graves relacionados con el corazón y cáncer con los medicamentos para la artritis y la colitis ulcerosa Xeljanz y Xeljanz de liberación prolongada (tofacitinib)

Los resultados iniciales de un ensayo de seguridad revela un mayor riesgo de padecer problemas graves relacionados con el corazón y cáncer con los ...

fda.gov

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease. FDA now ...

fda.gov

About Mineral - 613984 - 04/07/2021

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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October - December 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Signals of Serious Risks (FAERS)

fda.gov

Allure Imports - 613211 - 04/07/2021

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

fda.gov

FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer

FDA granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic ...

fda.gov

Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 Due to the Presence of Undeclared Tadalafil

Cliffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the ...

fda.gov

FDA approves new dosing regimen for cetuximab

Hematology / Oncology News Burst

fda.gov

Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 Due to the Presence of Undeclared Tadalafil

Cliffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the ...

fda.gov

Coronavirus (COVID-19) Update: April 6, 2021

fda.gov

Prostate Cancer: Symptoms, Tests, and Treatments

Prostate cancer is the most common cancer among men and the second most common cause of cancer-related deaths among American men. Learn more about the ...

fda.gov

Neoingenium Labs, SA de CV - 610499 - 03/31/2021

Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

fda.gov

RPK Pharmaceuticals Inc. - 613400 - 03/26/2021

Failure to Comply with Drug Listing Requirements/Misbranded

fda.gov

QMART Issues Voluntary Nationwide Recall of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 Due to Presence of Undeclared Sildenafil and/or Tadalafil

Elmwood Park, NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 to ...

fda.gov

Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry

fda.gov

Bioresearch Monitoring Information System (BMIS)

Bioresearch Monitoring Information System (BMIS) background page with download file.

fda.gov

A-S Medication Solutions Issues Voluntary Nationwide Recall of Acetaminophen Extra Strength Tablets Contained in Health Essentials Kits Due to Mislabeling

Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles ...

fda.gov

Coronavirus (COVID-19) Update: April 2, 2021

fda.gov

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease

Listen to an audio podcast of the March 31, 2021 FDA Drug Safety Communication that FDA review of studies show a potential increased risk of heart rhythm ...

fda.gov