Drugs
FDA has published a draft guidance, Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment, to assist sponsors in developing drugs or biological products for treating chronic rhinosinusitis with nasal polyps. The document has the agency’s current recommendations for trial population, design, effectiveness, statistical analysis, and safety for drugs
Drugs
FDA has published a guidance, Development of Anti-Infective Drug Products for the Pediatric Population, with general recommendations on the development of antibacterial, antifungal, and antiparasitic products for the pediatric population. The document says the agency encourages sponsors to discuss their initial pediatric study plans for anti-infective products with
Devices
FDA has approved a Thermo Fisher Scientific PMA for its Oncomine Dx Target Test as a companion diagnostic to help identify non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal growth factor receptor Exon20-insertion mutations for potential treatment with Janssen’s Rybrevant (amivantamab-vmjw). The device uses
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Fresenius Kabi NDA for Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection). The company notified the agency that the product is no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products. Comments on the document are being accepted until 3/9/2022. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is publishing modifications to its list of standards FDA recognizes for use in premarket reviews: “Modifications to the List of Recognized Standards, Recognition List Number: 056.” The list is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for
Drugs
FDA has published a draft guidance, Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products, as part of its mandate under the 21st Century Cures Act. The document discusses the applicability of the agency’s IND regulations
Drugs
FDA has published a guidance, CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports, with recommendations to holders of BLAs for specified biological products regarding the types of changes to an approved BLA to be documented in an annual report. The document says it describes
Devices
Entellus Medical and Jeffrey Gallups, founder, owner, medical director, and past-CEO of Milton Hall Surgical Associates (MHSA), that employed multiple physicians throughout north Georgia, have agreed to pay about $1.2 million and $3 million respectively to resolve allegations they violated the False Claims Act through an unlawful kickback
Drugs
The CDER Office of Strategic Planning has issued a Manual of Policies and Procedures establishing remote access best practices for conducting effective Web-based meetings including training sessions, workshops, division meetings, and town halls across the Center. The MAPP outlines procedures and responsibilities of all meeting participants to ensure Center
Drugs
FDA has lifted a clinical hold against an Aprea Therapeutics clinical trial evaluating the combination of its lead compound, eprenetapopt, with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. The action gives the company the green light to proceed with its future clinical study of eprenetapopt in non-Hodgkin&
Biologics
FDA has granted Pfizer and BioNTech an expanded emergency use authorization for their Covid-19 vaccine booster to include individuals 16 years of age and older. The booster dose is intended to be administered at least six months after completing a two-shot primary vaccination series. The companies say they
Drugs
FDA says its review of a Web site maintained by Synaptent, Chicago, IL, indicated that the company markets 17 dietary supplements that are legally considered to be unapproved new drugs. A just-released 11/09 Warning Letter lists some of the claims made for the supplements that establish that they
Drugs
FDA has released the FDA-483 issued following a 10/10-10/29 inspection at the Dr. Reddy’s sterile drug manufacturing facility in Duvvada, Andhra Pradesh, India. The eight inspection observations were: * the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed;
FDA Policy/General
Appearing in a Milken Institute video interview with former FDA commissioner Margaret Hamburg, current acting commissioner Janet Woodcock said she hopes incoming commissioner Robert Califf will continue modernizing information technology in the agency as well as continuing to work to lower sodium in food and shepherding several user fee programs
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations. The clinical recommendations specifically address the following clinical considerations: Ethical and human subject protection, diagnostic and genetic, dosing, administration, safety, and assessment
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations. The document provides FDA’s recommendations on the chemistry, manufacturing, and controls information needed to support an IND for
Drugs
Pfizer CEO Albert Bourla told CNBC 12/8 that the company will submit full data on its Paxlovid oral anti-viral Covid pill to FDA within a few days. He said Pfizer hopes for an agency decision on the company’s November emergency use authorization request this month. Bourla said
Drugs
FDA says it has released an updated version of the Clinical Outcome Assessment (COA) Compendium to encourage the development and implementation of patient-focused clinical outcome assessments in clinical trials to support drug approvals and labeling claims. The agency says the compendium is a communications tool that organizes and summarizes
Drugs
A Cleveland Clinic study says sildenafil (Viatris’ Viagra for treating erectile dysfunction and Revatio for treating pulmonary hypertension) is a promising drug candidate to help prevent and treat Alzheimer’s disease. Findings published by the Cleveland Clinic’s Genomic Medicine Institute in Nature Aging said researchers used computational methodology to
Devices
Anti-dental amalgam activists are rejoicing in a victory as Dentsply Sirona – the world’s largest manufacturer of dental products – has exited the amalgam market. In a 12/8 statement, Consumers for Dental Choice national counsel and World Alliance for Mercury-Free Dentistry president Charles Brown said the company had
Drugs
The Association for Accessible Medicines (AAM) says it applauds FDA for taking a bold step in developing a guidance on quality-related controlled correspondence “to mitigate duplicative work for both the industry and the agency.” FDA defines a controlled correspondence as a correspondence submitted to the agency by a generic