FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Mark Berman, Beverly Hills, CA (2/13): FDA inspected the physician’s operations 7/2018 and concluded he has been manufacturing a medical device known as the Pocket Protector,
FDA Policy/General
Comments Reopened on Real World Evidence Program Federal Register notice: FDA reopens the comment period on a 12/7/2018 notice entitled “Framework for a Real-World Evidence Program; Availability.” 02/15/2019 Panel to Discuss Breast Implant Benefit/Risk Federal Register notice: FDA announces a 3/25-26 General
FDA Policy/General
DEVICES FDA has expanded approval for an Abiomed PMA for the Impella CP heart pump and its use in high-risk percutaneous coronary interventions (PCI). In 2016, the agecny approved Impella CP for up to four days of use to treat patients suffering from cardiogenic shock. The expanded approval allows
FDA Policy/General
Federal Register notice: FDA is reopening the comment period on a 12/7/2018 notice entitled “Framework for a Real-World Evidence Program; Availability.” The agency is taking this action to allow interested people additional time to submit comments. Electronic or written comments on the document are now due by
FDA Policy/General
Federal Register notice: FDA has announced a 3/25-26 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are scheduled to discuss benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics: (1) Breast implant associated anaplastic
FDA Policy/General
Federal Register notice: CDER is providing an opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program. The program aims to propose explicit established conditions (ECs) as part drug submissions. The Center is implementing the program to gain experience receiving, assessing, and engaging with applicants
Devices
FDA has issued a draft guidance on Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which proposes a process where device companies can request nonbinding agency feedback on certain kinds of documented inspectional observations that are issued on a Form 483. The document outlines a standardized method for communicating
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda for use in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The submission is based on findings from the Phase 3 KEYNOTE-426 trial, which
Devices
FDA has finalized two guidance documents on regenerative medicine therapies that were issued as drafts 11/2017 as part of the agency’s comprehensive regenerative medicine policy framework. The first guidance, Evaluation of Devices Used with Regenerative Medicine Advanced Therapies, is intended to clarify how the agency will evaluate devices
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Exports: Notification and Recordkeeping Requirements — 21 CFR 1.101” (OMB Control Number 0910-0482). To view the notice, click here.
Drugs
FDA has issued a final rule that adds six bulk drug substances to its bulk substances listing that can be used by compounders not registered as outsourcing facilities. It also identifies four bulk drug substances that are not allowed to be used. “Developing the bulks lists for these compounders and
Devices
FDA has classified as Class 1 a Medtronic recall of its Dual Chamber Implantable Pulse Generators due to the possibility of a software error that can result in a lack of pacing. The implanted cardiac pacemakers are used to provide stimulation to increase heart rate in patients with a slow
FDA Policy/General
Federal Register notice: FDA has determined that Schering-Plough Healthcare Products’ Lotrimin (clotrimazole) topical solution, 1%, was not withdrawn from sale for safety or effectiveness reasons. The determination means that FDA will not begin procedures to withdraw approval of ANDAs that refer to the product, and it will allow the
FDA Policy/General
FDA has announced the appointment of Kaveeta Vasisht as deputy director of its Office of Women’s Health. She joined the agency in 2011 as a primary clinical reviewer and rose to be CDER Division of Clinical Trial Quality deputy director. An announcement says Vasisht will lead the scientific staff,
Devices
An 8/22-9/26/18 FDA inspection at Circulatory Technology, Oyster Bay, NY, found Quality System Regulation violations in the firm’s work as a specification developer of the Better Bladder and Bigger Better Bladder medical devices. A just-released 1/28 Warning Letter says the violations were: * failing
Drugs
FDA has accepted a Sarepta Therapeutics NDA seeking accelerated approval for golodirsen (SRP-4053), indicated for treating those individuals with Duchenne muscular dystrophy who have genetic mutations subject to skipping exon 53 of the dystrophin gene. The agency has set an 8/19 user fee review action target date. The
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.” The proposed program would make public a comprehensive listing of informally recognized standards in order to help promote innovation in pharmaceutical development and manufacturing and
FDA Policy/General
Federal Register notice: FDA has announced the withdrawal of a Takeda Pharmaceuticals NDA for Omontys (peginesatide) injection, indicated for treating anemia due to chronic kidney disease in adult patients on dialysis. The drug was approved in 2012, but in 2013 all lots were voluntarily recalled and marketing was suspended due
Drugs
A 3/26-4/4/18 FDA inspection at Vitalab Pharmacy, Phoenix, AZ, found “serious deficiencies in your practices for producing sterile drug products, which put patients at risk,” according to a just-released 1/10 Warning Letter. The letter acknowledges that on 4/4/18, upon receipt of an
Drugs
CDER is soliciting applications for an Established Conditions pilot program to propose explicit established conditions (ECs) as part of an NDA, ANDA, BLA, or prior approval supplement to any of those three. A Federal Register notice says the concept of ECs was first described in a 5/2015 FDA draft
Drugs
FDA has issued Motif Bio a complete response letter on its NDA for iclaprim for treating acute bacterial skin and skin structure infections. The letter indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved, according to the company. Motif
Devices
In a 2/13 Warning Letter, FDA says Dr. Mark Berman, Beverly Hills, CA, has been manufacturing a medical device known as the Pocket Protector, an expanded-polytetrafluoroethylene pouch used to line the inside of a breast pocket during breast augmentation procedures. The letter cites many of the marketing claims