Study says new drug applications are almost always disclosed by drug companies
A new research study in the JAMA Internal Medicine said most new drug applications are acknowledged by drug companies.
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GRIFOLS: Announces FDA Approval of Xembify®, 20% Subcutaneous Immunoglobulin for Primary Immunodeficiencies
Xembify® is Grifols' first 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies
GILEAD SCIENCES, INC.: Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year
Gilead Sciences, Inc. (NASDAQ: GILD) announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company provided an update about the investigational, oral, selective JAK1 inhibitor filgotinib.
FDA OK'd 227 drugs in June
The U.S. Food and Drug Administration approved 227 drug products in June, according to an online list the agency updated this week.
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PREMIER INC.: Premier’s ProvideGx™ Program to Make the First FDA-Approved Version of Cysteine Hydrochloride Available to Providers
Premier Inc. (NASDAQ: PINC), through its ProvideGx™ program, is now supplying cysteine hydrochloride injection to providers, a critical drug for pediatric and adult patients that require total parenteral nutrition (TPN). Cysteine hydrochloride has been in shortage in the U.S. since 2015.
LUMINEX CORPORATION: Luminex Submits ARIES MRSA Assay for FDA Clearance
Luminex Corporation (NASDAQ: LMNX) announced that the company submitted the ARIES® MRSA Assay to the U.S. Food and Drug Administration (FDA) for clearance on Friday, June 28, 2019.
LANNETT COMPANY, INC.: FDA Clears Path For The Continuing Review Of Lannett Company's New Drug Application
Lannett Company, Inc. (NYSE: LCI) commented on the U.S. Food and Drug Administration's (FDA) denial of a Citizen Petition submitted by Genus Lifesciences requesting that the FDA refuse to accept any submissions related to Lannett's 505(b)(2) New Drug Application (NDA) for Cocaine Hydrochloride Topical Solution, 4% and 10%.
U.S. FOOD AND DRUG ADMINISTRATION: FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps
The U.S. Food and Drug Administration is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and recommends that patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks.
Doctors, not FDA, should be empowered to deal with opioid crisis, association says
The Food and Drug Administration recently unveiled a new draft guidance for tackling opioid addiction, and scheduled a public hearing for Sept. 17 to discuss the crisis.
‘This is nuts’: FDA program set to help doctors navigate bureaucracy
Health care experts are expressing doubts about the FDA’s new call center, Project Facilitate, which is designed to assist physicians treating cancer patients.
U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses
The U.S. Food and Drug Administration issued warning letters to two marketers and distributors of kratom products – Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina – for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. The companies also make claims about treating pain, as well as other medical conditions like depression, anxiety and cancer.
HALEIGH'S HOPE: Haleigh's Hope, Inc. Lab Receives FDA Compliant, GMP Certification on Manufacturing Practices for All Hemp CBD Products Manufactured by the Company
Haleigh's Hope is proud to announce that they received GMP (Good Manufacturing Practices) certification
National Center for Health Research wants clearer information disseminated on device predicates
The nonprofit National Center for Health Research (NCHR) said it believes the FDA should make patients aware that devices in the 510 (k) program have not been sufficiently tested on humans through trials, like drugs are tested before being put on the market.
FDA approves new treatment for pediatric type 2 diabetes
The Victoza injection was approved by the U.S. Food and Drug Administration earlier this month for patients 10 years and older with type 2 diabetes.
Cannabis regulation not in FDA jurisdiction, industry expert says
The Food and Drug Administration has been gathering comments on how to regulate cannabis products, but a cannabis industry expert says FDA should lay off and let states do their jobs.
U.S., 27 EU nations join drug inspection accord
As of this month, 27 European nations are part of a mutual recognition agreement that allows regulatory agencies such as the U.S. Food and Drug Administration to rely on drug inspection data conducted within member nations.
U.S. FOOD AND DRUG ADMINISTRATION: Statement on agency’s efforts to increase transparency in medical device reporting
In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these products.
Should FDA be allowed to share in the profits during its approval process?
A Hawaii doctor opined in a column if the Food and Drug Administration should share in pharmaceutical and medical research profit.
FDA says foods with toxic PFAS chemicals are ‘not a concern’
Test results from the Food and Drug Administration on food with high levels of fluorinated chemicals known as PFAS were dismissed by two high level officials of the FDA.