FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Siga Technologies for gaining approval of a material threat medical countermeasure product application. In awarding the voucher, the agency determined that Siga’s NDA for TPoxx (tecovirimat), indicated to treat human smallpox disease in adults and pediatric patients weighing
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 16 NDAs from multiple applicants. The applicants notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 7/12 public meeting entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.” The meeting is intended to provide a public forum for FDA to listen to comments on a 6/2018 draft guidance on the limited population pathway. The agency is also
Drugs
An 8/13-8/29/18 FDA inspection at B. Jain Pharmaceuticals Pvt. Ltd., Rajasthan, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/21 Warning Letter says the specific violations were: * failing to maintain the buildings used in the manufacture, processing, packing,
Drugs
FDA has issued Warning Letters to operators of two Web sites that the agency says “illegally market potentially dangerous unapproved and misbranded opioid medications, including tramadol.” The letters tell the companies to immediately stop offering violative drugs for sale to U.S. consumers. The two Web sites are azmedicinalshop.com
FDA Policy/General
FDA has announced a 5/31 public hearing for it to receive input on the agency’s regulatory strategy and pathways for products containing cannabis or cannabis-derived compounds to be marketed. The agency is interested in hearing whether there are particular safety concerns that it needs to consider in
FDA Policy/General
FDA commissioner Scott Gottlieb and deputy commissioner for policy, legislation, and international affairs Anna Abram say the agency is implementing risk-based regulation of the safety and effectiveness of heritable intentional genomic alterations in animals. Writing in an FDA Voices blog post, the two say the innovations comprise changes made
Drugs
A 9/24-9/28/18 FDA inspection at Dong Yuan Technology Co., Shandong Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/18 Warning Letter says specific violations were: * failing to establish and follow laboratory controls that include scientifically sound and
Drugs
A New York federal judge has denied a Novartis motion for summary judgment in a whistleblower case alleging a decade-long company-wide kickback scheme through which the company paid doctors honoraria and other forms of remuneration for taking part in purportedly educational promotional programs to induce doctors to prescribe
FDA Policy/General
An FDA discussion paper is seeking comments on a proposed framework for modifications to artificial intelligence- and machine learning-based software as a medical device that is based on the internationally harmonized International Medical Device Regulators Forum risk categorization principles, FDA’s benefit/risk framework, management principles in the agency’
Drugs
FDA has issued Evoke Pharma a complete response letter on its 505(b)(2) NDA for Gimoti (metoclopramide) nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. The letter cites fewer issues than a company-received multidisciplinary review letter, Evoke says. It states that two
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Dong Yuan Technology Co. Shandong Province, China (3/18): FDA inspected the firm 9/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to
Drugs
FDA will hold a 5/13 public hearing to discuss access to affordable insulin products and issues related to development and approval of biosimilars and interchangeable insulin products. A Federal Register notice says the agency wants to hear input from patients, families, healthcare providers, and other stakeholders who live with
FDA Policy/General
Federal Register notice: FDA is proposing to amend the biologics regulations by removing the specified test for the presence of mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. The agency says the existing test for mycoplasma is restrictive in that it identifies
FDA Policy/General
Federal Register notice: FDA has issued a final rule amending general biologics regulations relating to time of inspection requirements and to remove duties of inspector requirements. FDA is taking the action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug and device
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