Drugs
FDA has published a draft guidance, Premenopausal Women with Breast Cancer: Developing Drugs for Treatment, with recommendations to sponsors developing drugs or biologic products regulated by CDER and CBER for treating breast cancer. The document specifically includes recommendations on the inclusion of premenopausal women in breast cancer trials. The issues
Devices
FDA says Battelle Memorial Institute, Columbus, OH, failed to meet medical device reporting (MDR) requirements included in an emergency use authorization (EUA) for its Battelle Critical Care Contamination System. The system is used for decontaminating certain N95 respirators for reuse by healthcare personnel where there are insufficient supplies of filtering
Biologics
CBER director Peter Marks says FDA could deploy the rarely-used “commissioner’s finding” to disclose Covid-19 vaccine safety information if such information is not provided by a vaccine manufacturer. Marks addressed the issue when asked about the clinical hold imposed in September on an AstraZeneca investigational Covid vaccine.
FDA Policy/General
[Editorial essay by David McFarland and Jim Dickinson] President Trump may have bent other federal agencies to his will, but FDA’s win 10/7 in getting the White House to back away (see earlier story) from threats to block a Covid-19 emergency use authorization (EUA) guidance showed that
Drugs
A 9/30 University of Kentucky petition asks FDA to recall one lot of acetazolamide manufactured by Mylan in India and one lot manufactured by Hikma in Portugal, due to insufficient active ingredient and/or increased impurities. A university news release says the Drug Quality Study at the UK HealthCare
Drugs
FDA has denied a 10/8/19 Public Citizen petition asking the agency to (1) withdraw approval of all medications containing hydroxyprogesterone caproate (HPC), approved and marketed as Amag Pharmaceuticals’ Makena and generics, and (2) place HPC on the list of drug products that have been withdrawn or removed from
FDA Policy/General
Federal Register notice: FDA has announced an 11/2 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to review an Olas Pharma NDA for Hydexor, a fixed-dose combination oral tablet containing hydrocodone, acetaminophen, and promethazine, indicated
Devices
The three leading Democrats on the House Energy and Commerce Committee say a new HHS policy to allow marketing of laboratory-developed tests (LDTs) without FDA review “could lead to numerous faulty tests on the market, raising serious concerns about the reliability of tests used to detect Covid-19. In
Drugs
Eton Pharmaceuticals has submitted an NDA for topiramate oral solution as a monotherapy for treating partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years of
Drugs
A 10/6 New York Southern District ruling in a Freedom of Information Act (FOIA) lawsuit found that FDA appropriately allowed company-directed redactions of commercial confidential information contained in Sarepta’s NDA for Duchenne multiple sclerosis drug Exondys 51 (eteplirsen). The lawsuit by New York University journalism professor Charles
Drugs
In a 9/30 ruling, the 3rd Circuit Court of Appeals rejected the Federal Trade Commission’s (FTC) authority to seek disgorgement under Section 13(b) of the FTC Act. Attorney Karin Moore (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the 3rd Circuit’s
Biologics
The White House 10/6 reversed its opposition to a controversial FDA guidance that outlines stricter requirements for granting an emergency use authorization (EUA) for potential Covid-19 vaccines. On 10/5, news got out that the White House still had objections to the pending guidance, first expressed in president
Drugs
Federal Register notice: FDA has announced the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2021. The vouchers are awarded to sponsors of rare pediatric disease product applications that meet all requirements of the program. The fee rate for FY 2021 is $1,360,
FDA Policy/General
FDA and Duke University’s Margolis Center for Health Policy are virtually holding 10/14 the 12th annual Sentinel Initiative public workshop. The national electronic system for medical product safety surveillance was mandated by the FDA Amendments Act to analyze drug safety data from multiple sources. “The virtual public workshop
Drugs
A 3/2-3/6 FDA inspection at the LEC Custom Products drug manufacturing facility in Brampton, Ontario, Canada, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/24 Warning Letter says specific violations were: * failing to use equipment in the manufacture, processing, packing,
Drugs
Researchers from Pfizer and several universities say that sponsors should consider alternative approaches to statistical analysis that could meet FDA expectations for demonstrating the interchangeability of biosimilars. Writing in the open-access journal BioDrugs, the researchers say it is challenging to conduct clinical studies to support an FDA designation of
Drugs
A 10/8-10/17/19 FDA inspection at Essential Pharmaceutical Corp., Pomona, CA, found the company produces adulterated and misbranded dietary supplements as well as an unapproved new drug. A 9/3 Warning Letter lists specific violations as: * manufacturing an unapproved new drug and marketing it as an over-
FDA Policy/General
Commenting on the FDA Interim Hiring and Retention Assessment conducted by Booz Allen Hamilton, Pharmaceutical Research and Manufacturers of America (PhRMA) says the agency needs to take immediate action if it is to make substantial progress on the PDUFA 6 and Biosimilar User Fee Act (BsUFA) 2 goals on FDA
Devices
FDA has approved Biosense Webster’s Thermocool SmartTouch SF Ablation Catheter for treating persistent atrial fibrillation (AF). Approval is based on data from the PRECEPT study which met primary safety and effectiveness endpoints and demonstrated that 80% of persistent AF patients experienced clinical success at 15 months after ablation therapy
Devices
FDA says it is seeking volunteers to participate in a pilot program for the electronic delivery of premarket submissions. The pilot is to provide an alternate method to submit a medical device premarket submission for 90 days during the Covid-19 pandemic. An agency online notice says the pilot’s
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Essential Pharmaceutical, Pomona, CA (9/3): FDA inspected the firm 10/2019 and found that the company produces adulterated and misbranded dietary supplements as well as an unapproved new
Devices
Senseonics Holdings has submitted a PMA supplement seeking to extend the wearable life of the Eversense Continuous Glucose Monitoring System from 90 to 180 days. The submission was based on data from the PROMISE clinical study. The 181-patient trial had participants have the Eversense sensor inserted subcutaneously at eight