Devices
FDA has cleared an Intellirod Spine de novo submission for its disposable spinal rod strain sensor, the LoadPro. The device clamps onto a standard 5.5mm rod for use in monitoring rod strain during kyphotic correction surgery. The initial clearance is for LoadPro with the Fortex pedicle screw system from
Drugs
Fresenius Medical Care has agreed to pay $231 million to resolve investigations by the Department of Justice (DoJ) and the Securities and Exchange Commission into violations of the Foreign Corrupt Practices Act related to its activities in various alleged corrupt schemes to obtain business in multiple foreign countries. According to
FDA Policy/General
Federal Register notice: FDA has issued a final rule to classify in vitro diagnostic devices for Bacillus species detection into Class 2 (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of device safety and effectiveness. An in vitro diagnostic device for
FDA Policy/General
Federal Register notice: FDA has issued a final rule to classify posterior cervical screw systems into Class 2 (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of device safety and effectiveness. The agency identifies a posterior cervical screw system as a
FDA Policy/General
Federal Register notice: FDA is amending the medical device reports of corrections and removals regulation to correct three inaccurate cross-references. This action is editorial in nature and is intended to improve the accuracy of the agency’s regulations. To view the notice, click here.
Drugs
Legislation introduced by Reps. Diana DeGette (D-CO) and Tom Reed (R-NY), who serve as the co-chairs of the Congressional Diabetes Caucus, would make permanent a new FDA policy that was put in place in December to help speed up the time it takes for biosimilars to get
Drugs
FDA has approved a Merck EMD Serono NDA for Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease. Mavenclad is not recommended for MS patients with clinically isolated syndrome, an agency release says. (XXINSERT LINKXX) The
Drugs
FDA has approved a Circassia Pharmaceuticals supplemental NDA to add new data to Tudorza Pressair’s (aclidinium bromide inhalation powder) prescribing information that includes data from the ASCENT trial showing that the therapy reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events in
Drugs
The Federal Trade Commission (FTC) has released an opinion and final order against generic company Impax Laboratories, finding that it engaged in an illegal pay-for-delay, or “reverse payment,” settlement to block consumers’ access to a lower-cost generic version of Endo Pharmaceuticals’s branded extended-release opioid pain
FDA Policy/General
Federal Register notice: FDA is proposing to amend and repeal parts of its radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The
Drugs
FDA has posted Warning Letters to four companies who produce homeopathic drug products, citing them for significant GMP violations. One letter was sent to King Bio (Asheville, NC), a firm the agency issued a safety alert about 8/2018. The Warning Letter to King Bio cites flaws in manufacturing operations
Drugs
Vertex Gains Priority Review Voucher Federal Register notice: FDA awards Vertex Pharmaceutical a priority review voucher after it determined that a qualified rare pediatric disease product gained approval. 03/29/2019 Proposed Rule Seeks Improved Mammography Services Federal Register proposed rule: FDA proposes to update the mammography regulations that were
FDA Policy/General
DEVICES FDA has cleared a Deerfield Imaging 510(k) to market its SYMBIS stereotactic brain biopsy system in the U.S. The device allows for a biopsy to be performed while a patient is inside an MRI scanner that is intended to improve targeting and procedure times. EDAP TMS has
FDA Policy/General
Pfizer Inc. and Allergan say they are not going forward with their $160 billion merger, in part because of new U.S. Treasury rules aimed at thwarting tax inversions. Pfizer has agreed to pay Allergan $150 million for reimbursement of expenses associated with the transaction. The National Institutes of Health
Drugs
Daiichi Sankyo says it is accelerating filing a BLA for [fam-] trastuzumab deruxtecan, an investigational HER2 targeting antibody drug conjugate in patients with HER2 positive metastatic breast cancer previously treated with ado trastuzumab emtansine (Genentech’s Kadcyla). The company says submission had been scheduled for 2020 but is now set
Drugs
FDA commissioner Scott Gottlieb, CDER director Janet Woodcock, and CBER director Peter Marks are urging drug companies to offer expanded access to patients who have been in a clinical trial after the trial ends. In a statement, the three say that sometimes drugs that have not shown benefit across the
Devices
FDA is proposing to amend and repeal parts of the radiological health regulations on recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. A Federal Register 4/
Drugs
The Institute for Safe Medication Practices (ISMP) says an FDA safety evaluation of Acadia Pharmaceuticals’ Parkinson’s drug Nuplazid (pimavanserin) that found no “new or unexpected” risks not covered in the labeling still leaves questions about the drug’s safety and efficacy unanswered. A CNN report says ISMP does not
FDA Policy/General
Just as he leaves the agency, FDA commissioner Scott Gottlieb has received the go-ahead for his proposed reorganization of the Office of the Commissioner and several changes to other agency elements. The Regulatory Affairs Professionals Society (RAPS) says Gottlieb told staff the reorganization plan “elevates the role of the
FDA Policy/General
Federal Register notice: FDA has awarded Vertex Pharmaceutical a priority review voucher after it determined that a qualified rare pediatric disease product gained approval. The agency recently approved the company’s Symdeko (tezacaftor/ivacaftor), indicated for treating patients with cystic fibrosis aged 12 years and older who are homozygous for
Drugs
FDA commissioner Scott Gottlieb believes that the most “enduring” accomplishment at the agency during his almost two-year stint is CDER’s ongoing new drug approval process reform and changing the nature of the application process to move away from a paper-based submissions. In a 3/29 sit-down
Drugs
Amarin has submitted a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules based on data from the REDUCE-IT cardiovascular (CV) outcomes study. “The REDUCE-IT results support that approximately one fewer major cardiovascular adverse event would occur on average for every six patients treated with Vascepa