Devices
The White House Office of Management and Budget (OMB) has completed its review of CDRH’s long-awaited proposed rule to modernize the medical device Quality System Regulation (QSR) by harmonizing and “supplanting” existing requirements with the specifications in the International Organization for Standardization’s (ISO) 13485:2016. OMB’s
Devices
FDA has approved Allergan Aesthetics’ Juvéderm Volbella XC for an additional indication — improving infraorbital (undereye) hollows in adults over the age of 21. As part of the approval, FDA is requiring the company to provide a product training program for all interested providers, which includes facial anatomy and considerations for
Drugs
A 5/11-5/27/21 FDA inspection at Innoveix Pharmaceuticals, Addison, TX, found serious deficiencies in the production of sterile drug products that put patients at risk. A 1/26 Warning Letter says the agency investigator found that drug products intended or expected to be sterile were prepared, packed,
Drugs
FDA has published an immediately-in-effect guidance, Covid-19 Public Health Emergency: Policy on Covid-19 Related Sanitation Tunnels, to discourage sponsors from developing or seeking approval or authorization for the use of sanitation tunnels. The document says sanitation tunnels are tunnels, walkways, chambers, and similar systems that spray
Drugs
FDA appears poised to be putting its foot down on drug sponsors conducting drug development programs that exclusively rely on foreign clinical trial data conducted in a single country. FDA Oncology Center of Excellence director Richard Pazdur tipped his hand (see story) late last week when he co-authored a
Drugs
FDA says CDER researchers are developing new methods and understandings to bridge the critical gap between the in vitro measurements and the in vivo performance of injectable suspensions. An agency online post says researchers developed new methods to understand the impact of flocculation (forming weakly bound agglomerates) state on drug
FDA Policy/General
Speaking on a 2/3 GovFocus panel, FDA acting chief technology officer Sohail Chaudhry said automation is a key element in the agency’s digital transformation plan, with user experience at the forefront of modernization efforts. “Data and people are at the heart of FDA,” he said. A Nextgov online
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Prescription Drug User Fee Program” (OMB Control Number 0910–0297). The agency is revising the collection to include its current commitment goals as set forth in the document “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Establishment Registration and Device Listing for Manufacturers and Importers of Devices — 21 CFR Part 807, Subparts A Through D” (OMB Control Number 0910-0625). FDA’s regulations require medical device establishment owners and operators to electronically submit
Drugs
The Oklahoma Firefighters Pension and Retirement System has filed a securities class action suit in Massachusetts federal court against Biogen and several of its top executives over the approval and marketing of its Aduhelm (aducanumab) to treat Alzheimer’s disease. The suit details Biogen’s declining profits from its multiple
Drugs
The Biotechnology Innovation Organization (BIO) has submitted comments on an FDA draft guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, listing four “overarching recommendations to improve the draft guidance.” The recommendations are: * considerations for prospective and retrospective real-world data (RWD); * considerations for mapping and
Drugs
Five King & Spaulding lawyers say a 12/2021 FDA draft guidance on digital health technologies (DHTs) is a “pandemic silver lining.” In an online post, the lawyers say the draft describes the agency’s thinking about how sponsors, study investigators, and others can use DHTs to gather health-related
Drugs
The Parenteral Drug Association (PDA) says it supports the concept of remote interactive evaluations (RIEs) of drug manufacturing and bioresearch monitoring facilities during the Covid-19 public health emergency. It thanks FDA for providing more information on its thinking on the subject in a guidance. The PDA letter says the
Devices
FDA has rejected a Pulse Biosciences 510(k) for an expanded indication to treat sebaceous hyperplasia with its cleared CellFX System powered by Nano-Pulse Stimulation technology. In a 2/5 Additional Information letter, the agency said the company had not provided sufficient clinical evidence at this time to support
Devices
Former CDRH orthopedic device medical officer Stephen Weber has joined consultant group NDA Partners. “During his FDA career, Dr. Weber conducted reviews of orthopedic devices including upper extremity devices, spine, hip, knee, and ankle devices, combination products, and surgical device products,” the company says. He was also a member of
Devices
FDA is warning health care providers, parents and caregivers of pediatric patients who receive enteral feeding that there is a risk of strangulation from using enteral feeding delivery sets. According to an FDA safety alert, the feeding set tubing can become wrapped around a child’s neck and cause strangulation
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Clinical Pharmacology Considerations for Antibody-Drug Conjugates,” which provides recommendations for developing such products. Specifically, the document addresses the agency’s current thinking on bioanalytical methods, dose selection and adjustment, dose- and exposure-response analysis, intrinsic factors, QTc assessments,
Drugs
The Department of Justice (DoJ) says it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims against the government in FY 2021. A department statement says it is the second-largest annual total in False Claims Act history and the largest
FDA Policy/General
Federal Register notice: FDA is classifying the carbon dioxide gas-controlled tissue expander into medical device Class 2 (special controls). The action was based on an AirXpanders de novo classification request for its AeroForm Tissue Expander System. The agency identified the device as being intended for temporary subcutaneous or submuscular
Devices
FDA has cleared an Ambu 510(k) for its Ambu aScope Gastro and Ambu aBox 2 display, the company’s first sterile single-use gastroscope, which includes new advanced imaging and next-generation display and processor technology. The sterile single-use device is intended to address growing cross-contamination risks,
FDA Policy/General
Federal Register notice: FDA is announcing a 2/15 Vaccines and Related Biological Products Advisory Committee meeting to discuss a request to amend the Emergency Use Authorization of Pfizer-BioNTech’s Covid–19 mRNA vaccine for administration to children six months through four years of age. To view the notice,
FDA Policy/General
Federal Register notice: FDA is classifying the alternate controller enabled infusion pump into medical device Class 2 (special controls). The action is based on a Tandem Diabetes Care de novo classification request for its t:slim X2 insulin pump with interoperable technology. To view the notice, click here.