FDA issued 34 warning letters to companies in June
The U.S. Food and Drug Administration issued 34 warning letters in June that were sent to manufacturers and other companies found to have violated FDA regulations.
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WUXI APPTEC: WuXi STA Shanghai & Changzhou Facilities Pass U.S. FDA Inspections
STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announces that its Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou, have successfully passed two inspections from the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued.
MIRUS: First System for Dynamic Intra-operative Measurement of Segmental and Global Spine Alignment Receives FDA Clearance
MiRus™ Receives FDA 510(k) Clearance for the GALILEO™ Spine Alignment Monitoring System
FDA expanding its drug approval process by incorporating ‘real world’ data and evidence
The U.S. Food and Drug Administration is using some new tools in its drug approval process and at least one prominent industry leader is giving the government entity a thumb’s up.
AVA president says parents should play of a role in banning sales of vape products to minors
The American Vaping Association says FDA fear-mongering on vaping products for minors could end up making the products more enticing.
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WATER STREET HEALTHCARE PARTNERS: Water Street's Partnership with Leading Medical Products Company Leads to FDA Approval of the First and Only Ready-to-Use Insulin for IV Infusion
Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that its development partnership with a leading medical products company has resulted in the U.S. Food and Drug Administration (FDA) approval of Insulin Human in 0.9% Sodium Chloride Injection (Insulin Human).
U.S. FOOD AND DRUG ADMINISTRATION: FDA suspends facility registration of Texas-based seafood producer after significant, repeated food safety violations
The U.S. Food and Drug Administration announced it has recently suspended the food facility registration of Topway Enterprises Inc., also doing business as Kazy’s Gourmet, of Houston, Texas. Topway now cannot sell or distribute any food into commerce.
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MED-EL: FDA Approves MED-EL USA’s Cochlear Implants for Single-Sided Deafness and Asymmetric Hearing Loss
MED-EL’s are the First and Only Cochlear Implants to Be Granted Indications for Traditionally Underserved Population
BAXTER: Announces U.S. FDA Approval of Myxredlin, The First and Only Ready-To-Use Insulin for IV Infusion
Offers extended shelf life of 30 days at room temperature or 24 months refrigerated
HORIZON THERAPEUTICS: Announces U.S. FDA Acceptance of its New Drug Application to Make PROCYSBI® (Cysteamine Bitartrate) Available as Oral Granules in Packets
Horizon Therapeutics plc (Nasdaq: HZNP) announced that the U.S. Food and Drug Administration (FDA) has accepted Horizon’s New Drug Application (NDA) for PROCYSBI® (Cysteamine Bitartrate) Delayed-Release Oral Granules in Packets.
CTI BIOPHARMA: Announces Outcome From End-of-Phase-2a Meeting With U.S. Food and Drug Administration (FDA) Regarding Pacritinib for Treatment of Myelofibrosis
Company Plans to Advance Pacritinib 200 mg Twice-Daily (BID) Dose to Phase 3 for Patients With Severe Thrombocytopenia
U.S. FOOD AND DRUG ADMINISTRATION: Federal judge enters consent decree against Arkansas food and medical product grocery warehouse for insanitary conditions
The U.S. District Court for the Western District of Arkansas ordered J and L Grocery, LLC. of Alma, Arkansas, the company’s owner, James T. White, and its manager, Lori A. Layne, to stop distributing food, drug products, medical devices and cosmetics until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.
Annual volume of FDA-regulated imported goods up 5-10%
Products imported into the United States that require screening by the Food and Drug Administration continue to increase at a rate between 5 and 10 percent annually, the FDA reports.
Q'APEL MEDICAL: Announces FDA Clearance for Walrus Balloon Guide Catheter
Q'Apel Medical announced that it received U.S. Food and Drug Administration clearance for its novel walrus Balloon Guide Catheter (BGC).
Botox approved for upper limb spasticity in children
The Food and Drug Administration approved drug company Allergan’s supplemental biologics application for Botox for patients 2-17 years old with upper limb spasticity.
MEMORIALCARE: Joins Innovative Effort to Solve Nation's Drug Shortage
Civica Rx partnership helps ensure essential, affordable, accessible generic medicines
INTEGRATED ENDOSCOPY Receives FDA Clearance for NUVIS Single-Use, HD, Battery Operated Arthroscope
Breakthrough Single-Use Endoscope Technology Approved for Arthroscopic Surgical Procedures
DURECT CORPORATION: Announces that the FDA Agreed to File the Full Response to the POSIMIR® Complete Response Letter as a Complete Class 2 Resubmission
User Fee Goal Date is December 27, 2019
VIVO System cleared by FDA
The VIVO (View Into Ventricular Onset) system from Catheter Precision has been cleared by the Food and Drug Administration for market release in the U.S.
NOVARTIS PHARMACEUTICALS CORPORATION: FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101)
FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease, shortening FDA review to six months from standard ten months