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.
Latest News
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.
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
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.
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
.jpg){kind=tracking}
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
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.
.jpg){kind=tracking}
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).
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.
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.
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
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.
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.
SOLITON, INC.: Soliton's FDA Cleared Device is Granted Key Patent
European Patent Office Approves Core Patent Covering Soliton's RAP Technology
LIPOCINE INC.: Receives FDA Clearance for Clinical Testing its NASH Candidate, LPCN 1144, in Expanded Target Population
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has received clearance from the U.S. Food and Drug Administration ("FDA") to clinically investigate LPCN 1144 in an expanded target population of adult male non-alcoholic steatohepatitis ("NASH") patients.
New drug application for Brinavess submitted to FDA
A New Drug Application (NDA) was resubmitted by Correvio Pharma Corporation to the Food and Drug Administration for the approval of Brinavess.
IMMIX BIOPHARMA, INC.: Immix Receives FDA Authorization to Expand Clinical Trial under US IND
Immix receives FDA letter activating the IND for IMX-110
.jpg){kind=tracking}
CORREVIO PHARMA CORP: U.S. FDA Accepts Correvio's Resubmitted New Drug Application For Brinavess (vernakalant)
NDA Seeks Approval for Brinavess for the Treatment of Recent Onset Atrial Fibrillation; PDUFA Date Set for December 24, 2019
CoolTone Device receives FDA approval
The CoolTone device from Allergan received Food and Drug Administration approval for use in improving abdominal tone and strength. CoolTone is already approved for strengthening, toning and firming of the buttocks and thighs.
QTBREATHEALTH: Brings FDA-cleared Technology for Radiation- and Compression-Free Breast Imaging to Scottsdale
Latest QTbreasthealth center now open within Scottsdale's Vincere Cancer Center, defining a new generation of breast imaging for women