FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that an Arog Pharmaceutical booth display and Web page for its investigational new drug Crenolanib besylate suggest that the drug is safe and effective for the purposes for which it is being investigated or otherwise promote the drug. A 6/28
Drugs
The Department of Justice has launched a Task Force on Market Integrity and Consumer Fraud authorized under an Executive Order signed by President Trump to focus on combating fraud against consumers — particularly the elderly, service members, and veterans — and corporate fraud that victimizes the general public and the government. Deputy
FDA Policy/General
FDA commissioner Scott Gottlieb says the agency’s FY 2019 budget request includes a $100 million medical data enterprise proposal to build a modern system that would rely on the electronic health records from some 10 million lives. Writing in an FDA Voice blog post, Gottlieb says the new system
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping” (OMB Control Number 0910-0230). To monitor drug safety and efficacy of marketed drugs, the agency has issued regulations to implement reporting and recordkeeping requirements on the
FDA Policy/General
Federal Register notice: FDA has announced an 8/3 joint Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee meeting. Panel members are scheduled to discuss results from assessments of the transmucosal immediate-release fentanyl medicines’ risk evaluation and mitigation strategy that was approved
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the letter. Zhuhai United Laboratories Guangdong, China (6/27): FDA inspected the firm 9/2017 and cited significant GMP deviations for active pharmaceutical ingredients. For
FDA Policy/General
Federal Register notice: FDA has announced an 8/7 Antimicrobial Drugs Advisory Committee meeting. Panel members will discuss an Insmed NDA for amikacin liposome inhalation suspension, indicated for treating nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen. To view
FDA Policy/General
FDA 7/3 posted the latest batch of Warning Letters while FDA Webview was closed for its annual holiday break. They can be accessed by clicking on the link following each letter. Foshan Jinxiong Technology Foshan City, China (6/26): FDA inspected the firm 8/2017 and cited significant GMP
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” The document’s recommendations are intended to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible,
FDA Policy/General
Federal Register notice: FDA is seeking comments on a information collection extension for “General Licensing Provisions; Section 351(k) Biosimilar Applications” (OMB Control Number 0910-0719). The collection is related to the Biologics Price Competition and Innovation Act of 2009 that amended the Public Health Service Act and other statutes
FDA Policy/General
DEVICES FDA has approved Bausch + Lomb’s Ultra contact lenses for extended wear for up to six nights and seven days of continuous wear. The contact lenses include the company’s MoistureSeal technology, a patented combination of material and manufacturing process that helps to maintain 95% of lens moisture for
FDA Policy/General
Draft Guide on Drug Indications Labeling Federal Register notice: FDA makes available a draft guidance entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” 07/09/2018 Comments Sought on Biosimilar Info Collection Federal Register notice: FDA seeks comments on a information
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The document addresses FDA’s implementation of the biosimilar user fee program and certain changes in policies and procedures. To view the notice, click here.
FDA Policy/General
In observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Monday, July 9. The next overnight email news bulletin from this site will be issued that evening.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.” The document discusses how to design appropriate nonclinical studies before beginning first-in-human trials and through product approval. In addition, it provides recommendations for product labeling, such as duration of
FDA Policy/General
Federal Register notice: FDA has announced an 8/22 public workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections.” Attendees will discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and Phase3 clinical trial designs to evaluate safety and efficacy. To view
FDA Policy/General
FDA has published a guidance, Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide, to help small businesses comply with the agency’s antimicrobial animal drug sales and distribution final rule. The document uses a question-and-answer format to help antimicrobial animal drug sponsors to annually report
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Biosimilars User Fee Program” (OMB Control Number 0910-0718). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 9/12 public hearing to solicit comments on its Predictive Toxicology Roadmap. The agency is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory reviews. To view
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer video of an interview featuring paid and trained Pfizer spokespersons about its Estring (estradiol vaginal ring) makes false or misleading claims and/or representations about the product’s risks and efficacy. A 6/19 notice of violation
FDA Policy/General
A new FDA report outlines the agency’s current workforce needs as mandated by the 21st Century Cures Act. New authority in the Act “provides tools to efficiently recruit and retain scientific, technical, and professional staff needed to continue advancing innovation and fulfilling FDA’ s mission,” the report says. The
FDA Policy/General
Public Citizen says FDA should immediately require the removal from the market of all medications containing the widely prescribed xanthine oxidase inhibitor febuxostat (Takeda’s Uloric) because (1) febuxostat increases the risk of death compared with alternative therapies and (2) there exist other effective medications that had been approved by