Devices
A state court jury in New Jersey has handed down a $33 million verdict against C.R. Bard in a product liability lawsuit involving its allegedly defective pelvic mesh implants. Numerous pelvic-mesh related lawsuits are consolidated in the state, according to Courtroom View Network (CVN). The Bergen County jury
FDA Policy/General
Federal Register notice: FDA has submitted to OMB for approval an information collection extension for “Notification of the Intent To Use An Accredited Person Under the Accredited Persons Inspection Program” (OMB Control Number 0910-0569). The notification is part of FDA’s voluntary third-party inspection program applicable to manufacturers
Drugs
FDA has alerted health care professionals about a recall of all non-expired products marketed as sterile made by Coastal Meds (Biloxi, MS) due to visible particles in some drug vials for injection. “Injection of a drug product containing particulate matter may result in serious and potentially life threatening adverse
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.” The International Council for Harmonization addendum provides updates to the original 2000 guidance and it does not alter the scope of the original guidance, which outlines an approach
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 18 ANDAs from multiple applicants. The ANDA holders have notified the agency that the drug products are no longer marketed and requested that their approval be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 5/4 Reagan-Udall Foundation annual public meeting to discuss its activities and how it supports the agency. The meeting will include a panel discussion on the “Evolution of FDA Science and Engagement” and the role of the Foundation. To view the notice,
Drugs
Premier Pharmacy Labs has recalled several lots of morphine sulfate, hydromorphone HCl and neostigmine methylsulfate due to a potential lack of sterility assurance. An FDA recall notice says that microbial contamination was detected during routine testing of subsequent unreleased product lots “due to interaction between the product syringe and tamper
Devices
FDA has approved a TransMedics PMA for the Organ Care System Lung platform for use in standard double lung transplants. Approval was based on data from the INSPIRE Trial, the first and largest controlled clinical organ preservation trial in lung transplantation that was conducted at 21 leading international academic institutions,
Drugs
Three Harvard Medical School researchers say that four years of experience with the FDA breakthrough therapy designation program indicate that while it has accelerated approval of some important drugs, the term “breakthrough designation” itself can be misleading to patients and healthcare providers. They suggest that Congress or FDA consider modifying
Drugs
FDA reportedly has opened a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine. Kaiser Health News reports that professor William Halford, who died 6/2017, injected subjects with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and
Drugs
FDA says that Haemonetics has received reports of low pH readings for platelets stored in the CLX HP bag in certain lots of the Acrodose Plus and PL systems, with the drop in pH being accompanied by a yellow discoloration of the storage bag in some cases. The agency says
Devices
Federal Register notice: FDA has made available a draft guidance entitled “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria.” The document describes an optional program for certain well understood device types, where a submitter could demonstrate that a new device meets FDA-identified performance criteria
Devices
FDA has finalized two guidances intended to drive development of next generation sequencing (NGS) that scans an individual’s DNA to diagnose genetic diseases and guide medical treatment. An agency statement (includes links to the guidances) says the documents provide recommendations for designing, developing, and validating tests that use NGS.
Drugs
A joint HHS/Justice Department Healthcare Fraud and Abuse Control Program won or negotiated over $2.4 billion in healthcare fraud judgments and settlements in FY 2017, according to a just-released report. In FY 2017, the report says, the Justice Department opened 967 new criminal healthcare fraud investigations. Federal
Drugs
FDA has approved a Novartis NDA for Afinitor Disperz (everolimus tablets for oral suspension) for the adjunctive treatment of adult and pediatric patients aged two years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Approval is based on data from the EXIST-3 Phase 3 study that
Drugs
Collegium Pharmaceutical is petitioning FDA not to approve any pending NDA for an extended-release (ER) oxycodone drug product, including Pain Therapeutics’ NDA for Remoxy ER, unless the product (1) bears abuse-deterrent labeling based on premarket studies conducted in each of the three categories in FDA’s 4/2015
FDA Policy/General
Federal Register notice: FDA is seeking the participation of consumer organizations in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels. The agency is also requesting nominations for voting and nonvoting consumer representatives to serve the panels. To view the notice, click here.
Drugs
FDA has released the FDA-483 with 13 observations issued following a 3/19-3/27 inspection at Alkem Laboratories, a Daman and Diu, India, drug manufacturing plant. The observations were: * there is no quality control unit; * the quality control unit lacks the responsibility and authority to approve and reject
Devices
FDA has published a draft guidance, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria, with the agency’s current thinking on expanding use of the abbreviated 510(k) program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. “The intent of the guidance is
Drugs
FDA has told AbbVie that it requires three more months to review additional information about the results of liver function tests provided by the company as part of its NDA for elagolix in endometriosis-associated pain. The user fee review action target date has been extended to the third quarter.
Devices
Innovative Health Solutions is petitioning FDA not to make a determination of certain subject devices’ substantial equivalence to its NSS-2 Bridge nerve stimulator without preclinical studies and at least one clinical trial establishing non-inferiority of the subject device to the NSS-2 Bridge in head-to-head evaluations.
Drugs
FDA has announced availability of four guidances issued by the International Council for Harmonization. They are: * Good Clinical Practice: Integrated Addendum – amends a previous guidance, Good Clinical Practice: Consolidated Guidance, to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also