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2021.04.15. csütörtök, Tas, Anasztázia
FDA
False & Misleading Claims/Misbranded
False & Misleading Claims/Misbranded
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry
FDA granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial cancer who ...
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 ...
Coronavirus (COVID-19) Update: April 13, 2021
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 ...
Mifeprex (mifepristone) Information
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
FDA is planning to implement eCTD validations in 2021 specific to submissions containing study data. FDA published the TRC to assist industry in understanding ...
Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety ...
MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, ...
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 ...
DDT COA #000116: PROMIS Itch Questionnaire – Children Impact (PIQ-C-Impact)
DDT COA #000140: PROMIS Itch Questionnaire – Children Symptom (PIQ-C-Symptom)
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 ...
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with ...
Remarks by Dr. Janet Woodcock, Acting Commissioner of Food and Drugs, 2021 Rx Drug Abuse and Heroin Summit, April 8, 2021
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 ...
Listen to a soundcast of the March 5, 2021 FDA approval of Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular ...
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 ...
Listen to a soundcast of the February 26, 2021 FDA approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adults patients with ...
Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease. FDA now ...
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
FDA granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic ...
Cliffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the ...
Hematology / Oncology News Burst
Cliffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the ...
Coronavirus (COVID-19) Update: April 6, 2021
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 ...
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Failure to Comply with Drug Listing Requirements/Misbranded
Elmwood Park, NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 to ...
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry
Bioresearch Monitoring Information System (BMIS) background page with download file.
Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles ...
Coronavirus (COVID-19) Update: April 2, 2021
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 ...
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