Devices
FDA has cleared an Oryx Dental 510(k) for its imaging product, Oryx Imaging. The medical device software provides health professionals the ability to acquire, view, annotate, and organize dental radiographs and color images, according to the company, which adds that it integrates with most dental imaging devices, such as
Devices
FDA has cleared a CTL Amedica 510(k) to market the CTL Amedica Navigation Instrument System. The device features manual surgical instruments adaptable for use with third-party navigation systems, which are designed to assist surgeons in locating anatomical structures for pedicle screw preparation and placement, the company says. It
Drugs
FDA has published a guidance, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors, to help human prescription drug and biological product sponsors, application holders, and applicants minimize medication errors associated with their products. The document provides a set of principles and recommendations for ensuring that
FDA Policy/General
The House Energy and Commerce Committee 5/18 unanimously voted (55 to 0) to advance the Food and Drug Amendments of 2022, bipartisan legislation that would reauthorize the agency’s user fee programs and modernize certain programs (see earlier story), such as enhancing post-approval studies for accelerated approval drugs,
FDA Policy/General
Federal Register notice: FDA has announced a 6/14 Science Board to the Food and Drug Administration Advisory Committee meeting. Panel members will consider challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study. They will also hear about
Devices
The federal government is suing The Prometheus Group, a New Hampshire manufacturer of pelvic muscle therapeutic systems and related rectal probes, and its president and sole owner Richard Poore, for violating the False Claims Act by causing healthcare providers to bill Medicare for services in which the providers improperly re-
Drugs
An 11/8-11/17/21 FDA inspection at the Colorful Products drug manufacturing facility, Newbury Park, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s manufacturing of over-the-counter topical drug products and hand sanitizers. A 5/10 Warning
Drugs
An 11/8-11/10/21 FDA inspection at Specialty Process Labs, a Phoenix, AZ, drug manufacturing facility, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 5/3 Warning Letter lists specific deviations as: * failing to demonstrate that the firm’s manufacturing
Biologics
FDA has amended the emergency use authorization granted for the Pfizer/BioNTech Covid-19 vaccine to authorize the use of a single booster dose in children 5-11 years old. The booster shot is to be given at least five months after completion of a primary series with the vaccine,
Drugs
FDA has accepted an scPharmaceuticals NDA for Furoscix (furosemide) delivered through an on-body infusor for treating congestion in patients with worsening heart failure. The agency has set a user fee review action target date of 10/8. The company describes Furoscix as a proprietary solution formulated to a neutral
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The document provides a set of principles and recommendations for ensuring that critical elements of a product’s container label and carton labeling are designed to
Biologics
Dark Horse Consulting Group has submitted to FDA a proposed draft guidance, Testing of Adeno-Associated Viral (AAV) Vector-Based Human Gene Therapy Products for Empty Capsids During Product Manufacture. The company says the development of the draft guidance was led by former CBER CMC reviewer Donald Fink, who has
Drugs
The National Academies of Science, Engineering, and Medicine has published Improving Representation in Clinical Trials, with recommendations for building research equity for women and underrepresented groups. The report (free PDF or purchase) says there is no doubt that past investments in clinical research to improve the health and well-being
Drugs
FDA has released the FDA-483 issued following an 8/16-9/8/21 inspection at Appollo Care, a Columbia, MO, outsourcing facility. The inspection observations were: * failing to put in writing and fully follow the responsibilities and procedures applicable to the quality control unit; * failing to establish, write, and
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” The document addresses changes in user fee assessments, payment procedures, reconsideration and appeals, and other additional information to assist industry in complying with the user fee program.
Drugs
Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) have introduced bipartisan legislation entitled the Retaining Access and Restoring Exclusivity (RARE) Act, which addresses a 2021 court decision that adversely impacts how FDA handles orphan drug exclusivity (see earlier story). A House Energy and Commerce Committee bill (see story)
FDA Policy/General
Senate Health, Education, Labor and Pensions Committee chair Patty Murray (D-WA) and ranking member Richard Burr (R-NC) have released a discussion draft of a bill that would reauthorize FDA user fee programs for another five years and enhance certain other program areas, like the regulation of diagnostic tests
Drugs
FDA has accepted for priority review a Travere Therapeutics NDA for sparsentan and its use in treating IgA nephropathy (IgAN). The company says it is seeking accelerated approval, and, if approved, sparsentan would be the first FDA-approved non-immunosuppressive treatment option for IgA nephropathy. The agency has set an
FDA Policy/General
Federal Register notice: FDA is debarring for five years Howard Stanley Head from importing or offering for import any drug into the U.S. In 11/2021, Head was convicted of conspiracy to import misbranded prescription drugs, under his business “Dr. Head’s Meds.” To view the notice, click here.
Drugs
FDA has released a revised final guidance entitled “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” The document discusses how to investigate OOS test results, including the roles/responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the
Devices
Avanos Medical has recalled (Class 1) its Cortrak 2 Enteral Access System due to reports of injuries and patient deaths after nasoenteric or nasogastric tubes have been misplaced. The device is intended to help with the placement of such tubes, but if a nasogastric or nasoenteric tube is inserted incorrectly,
Devices
FDA 5/16 issued an Emergency Use Authorization (EUA) for the Labcorp’s Covid-19+Flu+RSV Test Home Collection Kit for use with the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test. It is the first Covid-19 direct-to-consumer test that also detects and differentiates influenza A