FDA Update: electronic submissions statistics
Electronic regulatory submissions sent to the U.S. Food and Drug Administration have increased year-by-year since the electronic system was launched in 2009, the FDA reports.
Latest News
Drug-patent reform seeks accessibility, less data
As prescription drugs remain inaccessible to most, the notion of patent reform is seemingly settling into public discourse.
Republicans look to Fair Care Act of 2019 to improve health insurance system
Some in Congress are hoping the Republican sponsored Fair Care Act of 2019 will open the floodgates for Americans to buy health insurance.
CONCEPT MEDICAL INC.: Granted 2nd 'Breakthrough Device Designation' From the FDA for Its MagicTouch PTA Sirolimus Coated Balloon, for the Treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK) Indication
Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). The first 'Breakthrough Device Designation' received by Concept Medical Inc. was on 30th April 2019 for its MagicTouch SCB, for the treatment of Coronary Artery Disease (CAD) in patients with in-stent restenosis.
SHIMADZU MEDICAL SYSTEMS: Receives FDA 510(k) for the FLUOROspeed X1 RF system
Shimadzu Medical Systems USA, a subsidiary of Shimadzu Corporation, is proud to announce that they have received FDA 510(k) clearance for the FLUOROspeed X1, patient side conventional RF table system.
NINEPOINT MEDICAL: Announces FDA Clearance for Pancreatic and Biliary Applications of the NvisionVLE® Imaging System
NinePoint Medical, Inc., a transformative medical device company pioneering the use of a real-time optical imaging platform for gastrointestinal applications, announced that it has received U.S. Food and Drug Administration (FDA) clearance to market the NvisionVLE® Imaging System for use in the pancreas and bile duct.
Nektar Therapeutics, Bristol-Myers Squibb receive FDA breakthrough therapy designation
The U.S. Food and Drug Administration has granted breakthrough therapy designation for bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) based on clinical data from the 2019 American Society of Clinical Oncology (ASCO) annual meeting.
EndBrainCancer Initiative urges support, offers amendments
New guidelines proposed by the Food and Drug Administration are receiving support by the EndBrainCancer Initiative (EBCI). The new guidelines focus on diversity in clinical trials.
FDA policymaker to keynote hemp business summit
Leading authorities on hemp are set to gather next week in Portland, Oregon, in anticipation of learning more about upcoming regulations to the industry.
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PERFUZE: Receives Breakthrough Device Designation Status from U.S. Food and Drug Administration (FDA) for Millipede CIS (Clot Ingestion System)
Perfuze is developing novel catheter-based technology for treating acute ischemic stroke
KALA PHARMACEUTICALS: Receives FDA Complete Response Letter for KPI-121 0.25% NDA and Plans to Respond with Data From STRIDE 3 Trial
Targeting Topline Data from STRIDE 3 by the End of 2019
FDA Update: Mammography Procedure Numbers
Mammograms per year in the nation numbered more than 39.5 million as of Aug. 1, the U.S. Food and Drug Administration reports.
GILEAD SCIENCES: Statement on U.S. Food and Drug Administration Advisory Committee’s Recommendation on Descovy for PrEP™
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the U.S. Food and Drug Administration (FDA) recommended approval of Descovy®(emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for the proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex with men by a vote of 16 to 2.
NETFLEX: NextFlex’s Technology Hub Complies With FDA Standards for Manufacturing of Medical Devices
Adherence to FDA Quality Standards Will Boost Ability of Fabrication Facility to Produce Pilot-Scale Devices for NextFlex Members and Customers
NORD: Funded By FDA, C-Path And NORD To Launch Rare Disease Data Analytics Platform
The collaborative project between the organizations will kick off at a launch meeting in September and will aim to reduce barriers for the development of new treatments and cures for rare diseases
THERMO FISHER SCIENTIFIC: New Expanded Analytical Instrument Portfolio of U.S. FDA Class I Medical Devices for Clinical Diagnostic Laboratories
Thermo Scientific Medical Device portfolio provides an extensive range of chromatography and mass spectrometry instruments for performing laboratory developed tests
DALENT MEDICAL: Sinusleeve™ Balloon Device Completes FDA Listing, Dalent Medical Begins Sales In South Florida
Dalent Medical, a Miami-based company developing innovative devices for Ear, Nose & Throat Doctors is pleased to announce that the Sinusleeve™ Balloon Sinus Dilation Sleeve has completed the United States Food and Drug Administration's listing process.
INOTREM: Announces FDA Clearance of Investigational New Drug (IND) for the Phase IIB ASTONISH Trial in Septic Shock Patients to Demonstrate Nangibotide Efficacy
Inotrem S.A., a biotechnology company specialized in immunotherapy for acute inflammatory syndromes, announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for the ASTONISH trial (Phase IIb) where the safety, tolerance and efficacy of nangibotide (LR12), its lead compound for septic shock, will be studied.
U.S. FOOD AND DRUG ADMINISTRATION: FDA statement on court ruling related to compounded bulk drug substances and the agency’s ongoing efforts to implement its compounding authorities
FDA statement on court ruling related to compounded bulk drug substances
FDA issued 14 warning letters to companies in July
The U.S. Food and Drug Administration issued 14 warning letters in July that were sent to manufacturers and other companies found to have violated FDA regulations.