Public Notification: Hydro Pinapple [sic] Burn contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Hydro Pinapple [sic] Burn, a product promoted and sold for weight loss on various websites, including www.Ebay.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 26, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Tainted Weight Loss Products
FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 26, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Seeks Patient Insight: Call for Applications for the Patient Engagement Collaborative
The FDA is announcing the call for applications for the next cohort of the Patient Engagement Collaborative. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 22, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma
- Oncology - Cancer (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 22, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Fill It Pack It Inc - 570946 - 07/19/2021
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 21, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Fill It Pack It Inc - 570946 - 05/02/2019
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 21, 2021 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

Jordan ’s Crossing Herbal Connections - 616001 - 07/20/2021
Unapproved and Misbranded 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 - July 21, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Pharmacodynamic Biomarkers for Biosimilar Development and Approval - 09/20/2021 - 09/21/2021
Pharmacodynamic Biomarkers for Biosimilar Development and Approval (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 20, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Statins: Drug Safety Communication - FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During Pregnancy
FDA is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 20, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy. Despite this change, discontinue statins in most pregnant patients or consider the ongoing therapeutic needs of the individual patient. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 20, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil - 614402 - 07/08/2021
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 20, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Remarks by Dr. Woodcock to the Regulatory Education for Industry Conference - 07/19/2021
Remarks by Janet Woodcock, MD Acting Commissioner of Food and Drugs 2021 FDA Regulatory Education for Industry Conference July 19, 2021 White Oak, MD (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX ® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily I (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines
A major paradigm shift is necessary from the systemic exclusion to the inclusion of pregnant and breastfeeding women in clinical studies. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 19, 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 - July 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Updates and Press Announcements on Nitrosamine in Varenicline (Chantix)
FDA Updates and Press Announcements on Nitrosamine in in Varenicline (Chantix) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves belumosudil for chronic graft-versus-host disease
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

2021 Compounding Quality Center of Excellence Virtual Conference: Culture of Quality - 09/14/2021 - 09/15/2021
Attend the 2021 Compounding Quality Center of Excellence Virtual Conference! to learn how focusing on quality can improve patient safety and and product quality. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific NEUTROGENA ® and AVEENO® Aerosol Sunscreen Products Due to the Presence of Benzene
Johnson& Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five NEUTROGENA ® and AVEENO® aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products and fol (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or misleading promotional communications about the product ’s benefit
The Food and Drug Administration (FDA) has issued an untitled letter to Amgen Inc. for the misbranding of its biological product, Neulasta (pegfilgrastim) injection, for subcutaneous use, resulting from a false or misleading promotional communication. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

2021 FDA/PDA Joint Regulatory Conference - 09/27/2021 - 09/29/2021
2021FDA/PDA Joint Regulatory Conference (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of All Sterile Compounded Drug Products Due to A Lack of Sterility Assurance
Innoveix Pharmaceuticals, Inc. is voluntarily recalling the following lots of sterile compounded drug products, within expiry. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Phoenix Nutritionals, Inc. - 613909 - 07/01/2021
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 - July 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CURE ID Moves to Automated Data Collection in Light of COVID Pandemic
This grant will allow ClinMeth to work with partners over the next two years to expand the open-access CURE ID platform of case reports to include anonymized electronic health record (EHR) and registry data. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Dream Pharmacy 24/7 Enterprises Limited 2018 - 614898 - 07/01/2021
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 - July 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Guangzhou Minghui Cosmetics Co., Ltd. - 610575 - 07/06/2021
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 - July 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

UPDATED TIME INFORMATION: July 15, 2021 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement - 07/15/2021 - 07/15/2021
July 15, 2021 Meeting of the Cardiovascular and Renal 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 - July 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

January - March 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 - July 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

2021_07 Test Article FT 01
2021_07 Test Article some long description some long description. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves avapritinib for advanced systemic mastocytosis
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 - July 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma
Hematology / Oncology News Burst FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA to Discuss COVID-19 ’s Impact on Medical Product Operations at SBIA REdI Annual Conference
FDA will co-host the Small Business Industry and Assistance (SBIA) Regulatory Education for Industry (REdI) Annual Conference, which will provide an overview of our regulatory operations during COVID-19. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 9, 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 - July 9, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: X Rated Honey For Men contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use X Rated Honey For Men, a product promoted and sold for sexual enhancement on various websites, including www.adameve.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 9, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Cholestene contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Cholestene, a product promoted and sold for cholesterol management on various websites and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 9, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Halodine, LLC - 611150 - 07/07/2021
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 - July 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Clinical Data Summary Pilot Program
CDER has launched a pilot program to assess the feasibility of using a different format to provide required summaries of the safety and effectiveness information that is used to make regulatory decisions. The pilot program will include up to nine recently submitted new drug applications (NDAs). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Development Tool Qualification Process: Transparency Provisions
Under the 21st Century Cures Act enacted on December 13, 2016, the new section 507 Qualification of Drug Development Tools was added to the Federal Food, Drug, and Cosmetic Act and formally establishes an updated, multi-stage process for DDT qualification. This process includes three submission milestones and transparency provisions that address requestors ’ submissions and FDA’s formal written determinations in response to such submissions. The transparency provisions of section 507 will apply only to submissions (LOIs, QP, and FQPs) sent to FDA after December 13, 2016 (when the 21st Century Cures Act was enac...
Source: FDA Center for Drug Evaluation and Research - What's New - July 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Resources for Biomarker Requestors
Information and resources for requestors about FDA ’s Biomarker Qualification Program (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Stason Pharmaceuticals, Inc. - 604889 - 06/24/2021
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Spectrum Laboratory Products, Inc. - 573311 - 06/24/2021
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 - July 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Spectrum Laboratory Products - 573311 - 06/04/2019
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 - July 6, 2021 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

Results RNA, LLC - 578997 - 06/24/2021
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Results RNA, LLC - 578997 - 07/29/2019
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 6, 2021 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

FDA ’s Budget: Data Modernization and Enhanced Technologies
FDA ’s FY 2022 Budget includes funding for an agency-wide data modernization and enhanced technologies initiative that supports both food safety and medical product safety programs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Ensuring the Rigor of Regulatory Science: CDER Conducts Laboratory and Clinical Studies to Investigate Reports of NDMA Production from Ingested Ranitidine Products
Ranitidine, which blocks histamine-induced acid secretion in the stomach, was approved in 1983. It became widely used over the ensuing decades as a prescription and over-the-counter product. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 2, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Ardil Comercial Issues Voluntary Nationwide Recall of Limar Hand Sanitizer Packaged in 4 oz Bottles Because They Resemble Drink Containers
Santo Domingo, Dominican Republic – Ardil Comercial is voluntarily recalling one lot of Limar Hand Sanitizer, packaged in 4 oz bottles to the consumer level. The hand sanitizer is being recalled because it is packaged in containers that resemble water bottles. The product poses a risk of ingestion (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 1, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news