Devices
FDA has cleared a CereMetrix 510(k) for its neuroimaging analytics and quantification platform CereMetrix Silver. The device allows healthcare providers to have access to objective neuroimaging that detects, quantifies and analyzes brain function down to the voxel level, according to the company. The image viewer is designed to analyze
Biologics
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with advanced cervical cancer that is progressing on or after chemotherapy. This is the first submission for an anti-PD-1 therapy in cervical cancer, and the agency has set a user fee review
Devices
Hyman, Phelps & McNamara says an FDA draft guidance on the concept and principles behind the “least burdensome” provisions is extremely important because the concept is a fundamental principle implicated by many FDA decisions that the agency still has not adequately implemented. “Repeated experience has shown that FDA has not
Drugs
FDA has placed on clinical hold an Advaxis IND for a Phase 1/2 combination study of axalimogene filolisbac with AstraZeneca’s Imfinzi (durvalumab) for treating patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The company says the hold
Devices
A 12/4-12/14/17 FDA inspection at Laser Dental Innovations, a San Jose, CA, manufacturer of dental handpiece and laser fiber optic surgical devices, found Quality System Regulation violations, according to a 2/27 Warning Letter. Specific violations cited were: * failing to establish procedures for implementing corrective and
Drugs
Rep. Frank Pallone (D-NJ) has introduced HR 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now (SCREEN) Act, to increase funding to and expand FDA authority to prevent illegally manufactured opioids, including heroin and fentanyl, from arriving through the mail from overseas.In a statement (includes link
Devices
An 8/28-8/31/17 FDA inspection at Dexcowin Co., Ltd., Seoul, Korea, found 13 violations of Quality System Regulations, according to a 2/20 Warning Letter. Specific violations cited were: * failing to establish and maintain adequate procedures for implementing corrective and preventive action; * failing to establish and maintain
Drugs
FDA has released the FDA-483 issued following a 2/6-2/15 inspection at Biocon Sdn Bhd, a Johor, Malaysia, sterile drug manufacturer. The inspection observations were: * failing to establish or follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * failing to thoroughly review
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Dexcowin Co. Seoul, Korea (2/20): FDA inspected the firm 8/2017 and cited GMP deficiencies with manufactured portable dental diagnostic X-ray devices. For example, the firm failed
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “M7(R1): Assessment and Control of Deoxyribonucleic Acid (DNA) Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.” The International Council for Harmonization document updates and replaces a 5/2015 guidance under the same title. The new guidance provides
FDA Policy/General
Federal Register notice: FDA has submitted to OMB for approval a new proposed information collection for a drug direct-to-consumer (DTC) broadcast advertising study entitled “Utilization of Adequate Provision Among Low to Non-Internet Users.” The primary focus will concern the ability and willingness of low to non-Internet
Drugs
FDA has announced new research to be conducted on direct-to-consumer (DTC) ads — “Utilization of Adequate Provision Among Low to Non-Internet Users.” Agency regulations require that broadcast advertisements contain a brief summary of side effects and contraindications or that “adequate provision” be made for dissemination of the approved
Drugs
Federal Register notice: FDA has submitted a proposed collection of information to OMB for review and clearance — “Transfer of a Premarket Notification.” The information collection is related to a draft guidance on “Transfer of a Premarket Notification (510(k)) Clearance — Questions and Answers,” which is intended to provide information on
Devices
FDA is alerting healthcare providers to the potential for increased “image artifact” or image voids associated with magnetic resonance angiography imaging for patient follow-up of certain post neurovascular embolization coil procedures. The coils are used in treating brain aneurysms and other vascular abnormalities. “As aneurysms treated with coils may
Drugs
FDA has reaffirmed a 2017 complete response letter denying approval of a Hikma Pharmaceuticals ANDA for a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder). In a just-concluded dispute resolution action, FDA has upheld its complete response action that requested the completion of an
Devices
FDA has cleared a DeGen Medical 510(k) for the E3 MIS Modular Pedicle Screw System for thoraco-lumbar spine. The device is designed to address a wide range of surgical options, pre-assembled or modular screws, straight or curved rods, and titanium or cobalt-chrome rods, according to the
Devices
FDA has approved a Medtronic PMA for its Guardian Connect continuous glucose monitoring (CGM) system for people with diabetes ages 14 to 75 years. The device is described by the company as the first smart standalone CGM system to help people with diabetes stay ahead of high and low glucose
Devices
A jury in Northern District of Indiana federal court has returned a $35 million verdict in favor of plaintiffs Barbara and Anton Kaiser for alleged injuries Barbara suffered from Ethicon’s Prolift transvaginal mesh. The nine jurors found that the company negligently designed the device and failed to adequately warn
Drugs
A revised “Right to Try” bill has been introduced in the House to improve access to experimental treatments for patients. “This updated ‘Right to Try’ bill is the direct result of conversations with our colleagues, the administration, and stakeholders on all sides of the issue,” said House Energy and Commerce
FDA Policy/General
Doryx Not Withdrawn Due to Safety/Effectiveness: FDA Federal Register notice: FDA determines that Mayne Pharma International’s Doryx MPC (doxycycline hyclate), delayed-release tablets, 60 mg, were not withdrawn from sale for safety or effectiveness reasons. 03/09/2018 Advisory Committee Docket Number Corrected Federal Register notice correction: FDA
FDA Policy/General
Biogen has agreed to purchase Pfizer’s PF-04958242, a first-in-class, Phase 2b-ready drug being evaluating to treat several neurological and psychiatric diseases, including schizophrenia. Biogen is paying $75 million upfront for the compound, and the agreement could include up to $515 million in developmental and commercial
FDA Policy/General
Federal Register notice: FDA has determined that Mayne Pharma International’s Doryx MPC (doxycycline hyclate), delayed-release tablets, 60 mg, were not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference Doryx if all other legal and regulatory requirements are met.