FiercePharma12d
FDA issues Form 483s to Japanese, Indian drugmakers in wake of plant inspections
Two Japanese drugmakers and another in India were hit with Form 483s from the FDA following inspections that uncovered issues ...
pharmaphorum29d
FDA forms a view on pharma use of social media
FDA marketing regulations include pharma employees' Facebook (In-Pharma Technologist). FDA hands pharma marketers another piece of social-media guidance (FiercePharma). Reference link: ...
Medscape8d
Using Preprinted Medication Order Forms to Improve the Safety of Investigational Drug Use
Standard components of the forms include the subject name, subject study number, and the names and contact information of the authorized prescribers of the study drug. The drug name, dosage ...
FDA approves ‘FluMist,' says no healthcare provider needed
FluMist is the first vaccine to prevent influenza that does not need to be administered by a healthcare provider, the ...
Investopedia12d
Food and Drug Administration (FDA): What It Is and Does
Her expertise is in personal finance and investing, and real estate. The Food and Drug Administration (FDA) is a government agency that is responsible for the promotion and protection of public ...
US FDA approves AstraZeneca's self-administered nasal spray flu vaccine
The U.S. Food and Drug Administration said on Friday it has approved AstraZeneca's nasal spray flu vaccine for ...
USA Today22d
FDA authorizes Novavax's updated COVID-19 vaccine
The U.S. Food and Drug Administration on Friday granted emergency use authorization for an updated version of Novavax's COVID shot. The updated vaccine is authorized for use in individuals 12 ...
FiercePharma24d
API maker Global Calcium stung with Form 483 filing after FDA inspection of Indian plant
Following an inspection that ran from July 29 to Aug. 2, the FDA handed Global Calcium a six-observation Form 483. The heavily redacted document was posted online by the U.S. regulator on Wednesday.
Forbes22d
FDA Approves Updated Novavax COVID Vaccine Week After Approving Moderna And Pfizer’s Shots
The Food and Drug Administration approved Novavax’s new COVID-19 vaccine Friday, a week after giving Pfizer and Moderna the OK on their shots, though all drugmakers say their shots will be ...
Yahoo Finance4d
Merck's Keytruda Secures First FDA-Approval For Rare Form Aggressive Cancer
Wednesday, the FDA approved Merck & Co Inc’s (NYSE ... MPM is a rare, aggressive cancer that forms in the lining of the lungs and chest. The approval is based on pivotal Phase 2/3 IND.
UPI21d
FDA approves Novavax's updated COVID-19 vaccine
The U.S. Food and Drug Administration on Friday authorized the updated version of the protein-based Novavax Covid-19 vaccine for use in people 12 and older. Advertisement One week ago, the FDA ...
Benzinga.com4d
Merck's Keytruda Secures First FDA-Approval For Rare Form Aggressive Cancer
The approval marks first indication for Keytruda in MPM in the US, MPM is a rare, aggressive cancer around the lining of the lungs and chest Wednesday, the FDA approved Merck & Co Inc’s MRK ...