FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
The U.S. Food and Drug Administration today approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm) is now approved as interchangeable with (and may be substituted for) its reference product Humira (adalimumab). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 18, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer
Oncology News Burst (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity
Baltimore, Maryland, October 14, 2021: Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin ’s ongoing assessment, analysis revealed that certain tested API batches (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Q13 continuous manufacturing of drug substances and drug products
ICH - Quality (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA ’s Advanced Manufacturing Initiatives Helping to Provide Quality Human Drugs for Patients
FDA has established numerous initiatives, including the development of a research program to better understand the science of advanced manufacturing. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves add-on drug for adults with rare form of blood vessel inflammation
FDA has approved Tavneos (avacopan) as an add-on treatment to standard therapy including glucocorticoids for adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. Tavneos helps to reduce blood vessel inflammation and offers patients an additional t (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves pembrolizumab combination for the first-line treatment of cervical cancer
Oncology News Burst (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Jobs at the Center for Drug Evaluation and Research
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves abemaciclib with endocrine therapy for early breast cancer
Oncology News Burst (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Teligent Pharma, Inc. ’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency
Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling the five lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Speci (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coronavirus (COVID-19) Update: October 12, 2021
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Clinical Investigator Training Course (CITC) Update - 12/07/2021 - 12/08/2021
Clinical Investigator Training Course (CITC) Update December 7-8, 2021 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Notarika, S.A. de C.V. - 609174 - 10/07/2021
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

HealthMEDS Inc. - 618484 - 09/29/2021
Failure to permit access to or copying of records (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Missouri Analytical Laboratories Inc - 615319 - 09/30/2021
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. - 616560 - 09/30/2021
Bioresearch Monitoring Program/IRB (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

GuangZhou YouXing Cosmetic Co., Ltd - 610709 - 09/30/2021
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CDER Conversation: Novel Excipient Review Pilot Program
FDA ’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review. The pilot program offers a new pathway for drug manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CDER Conversations
Interviews with FDA scientists regarding current events relating to the FDA. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA recognizes Memorial Sloan-Kettering database of molecular tumor marker information
Oncology News Burst (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Clinical Trial Design for Non-Muscle Invasive Bladder Cancer (NMIBC) - 11/18/2021 - 11/19/2021
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) and Center for Drug Evaluation and Research (CDER) welcome you to this FDA Virtual Public Workshop: Clinical Trial Design for Non-Muscle Invasive Bladder Cancer (NMIBC). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Remarks by Acting Commissioner Woodcock at the Global Summit on Regulatory Science Research - 10/05/2021
Remarks by Janet Woodcock, MD Acting Commissioner of Food and Drugs Global Summit on Regulatory Science Research National Center for Toxicological Research Jefferson, Arkansas October 5, 2021 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals
ICH - Safety (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
Compounding (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

A Practical Research Agenda for Treatment Development for Stimulant Use Disorder - 10/18/2021 - 10/18/2021
CDER Meeting (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

ICA Health, LLC/Future Formulations, LLC - 614383 - 09/20/2021
New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Walfer Corporation dba The Medicine Shoppe Pharmacy - 611017 - 09/17/2021
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 - October 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Limpo Quimicos, SA de CV - 608859 - 09/30/2021
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

True Chemical Solutions, LLC - 616672 - 09/29/2021
Failure to Permit Access to or Copying of Records (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Healthy Foods & Nutrition Lab de Mexico S.A. de C.V. - 609608 - 09/29/2021
Unapproved New Drugs/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Ardil Comercial S.R.L. - 612018 - 09/22/2021
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia
Oncology News Burst (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 1, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Bayer Issues Voluntary Recall of Specific Lotrimin ® and Tinactin® Spray Products Due to the Presence of Benzene
Bayer is voluntarily recalling all unexpired Lotrimin ® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 1, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coppertone ® Issues Voluntary Nationwide Recall of Specific Lots of Pure & Simple SPF 50 Spray (2021 Launch), Sport Mineral SPF 50 Spray (2021 Launch), and Travel-Size Coppertone ® Sport Spray SPF 50 (1.6OZ) Aerosols Sunscreen Sprays Due to the Presence of Benzene
Coppertone, owned by Beiersdorf, is voluntarily recalling specific lots of five Coppertone aerosol sunscreen spray products manufactured between the dates of January 10, 2021 and June 15, 2021 to the consumer level. Coppertone has identified the presence of benzene in these lots of products. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Regulatory Education for Industry (REdI): FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials – Are We There Yet? October 23-24, 2018 - 10/22/2018 - 10/24/2018
This workshop will provide FDA CDER and MHRA perspectives on the importance of quality management practices on data reliability. It will provide regulatory perspectives on data management, data blinding to minimize introduction of bias, and the role of audit trails. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Strategia Project Management, Inc. - 615307 - 09/28/2021
Unapproved New Drug 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 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves weekly therapy for adult growth hormone deficiency
FDA approved Sogroya (somapacitan) on August 28 for adults with growth hormone deficiency. Sogroya is the first human growth hormone (hGH) therapy that adult patients only take once a week; other FDA-approved hGH formulations for adults with growth hormone deficiency must be administered daily. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA ’s approval of Veklury (remdesivir) for the treatment of COVID-19—the science of safety and effectiveness
FDA recognizes that patients affected by coronavirus 2019 (COVID-19) are in great need of medicines to treat this disease. To help meet this need, the agency is helping to speed the development of promising therapies through its Coronavirus Treatment Acceleration Program (CTAP). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves weight management drug for patients aged 12 and older
The U.S. Food and Drug Administration has approved Saxenda (liraglutide) for chronic weight management among patients aged 12 and older who are obese. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves treatment for ebola virus
The FDA approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

April - June 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Signals of Serious Risks (FAERS) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves add-on therapy for patients with genetic form of severely high cholesterol
FDA has approved Evkeeza (evinacumab-dgnb) injection as an add-on treatment for patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves first treatment for disease that causes recurrent inflammation in sac surrounding heart
Alert (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves drug to reduce risk of serious kidney and heart complications in adults with chronic kidney disease associated with type 2 diabetes
FDA has approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal hearts attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves new use of transplant drug based on real-world evidence
Approval of Prograf (tacrolimus) Using Real-World Evidence (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves add-on therapy for patients with genetic form of severely high cholesterol
FDA has approved Praluent (alirocumab) injection for adult patients with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves new treatment for adults with serious rare blood disease
FDA has approved Empaveli (pegcetacoplan) injection to treat adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening blood disease. Empaveli is the first PNH treatment that binds to compliment protein C3. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Enhancing Benefit-Risk Assessment in Regulatory Decision-Making
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Q3B(R) Impurities in New Drug Products (Revision 3)
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 29, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Benefit-Risk Assessment for New Drug and Biological Products
Clinical / Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 29, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news