Chemicon Inc. reg letter
Executive Summary
Firm received an Oct. 5 reg letter for manufacturing and distributing numerous prescription drugs, including minoxidil lotion (Upjohn's Rogaine) and tretinoin cream (Ortho's Retin-A). The drugs are "misbranded in that their labeling fails to bear adequate directions for use for the conditions for which the articles are represented and suggested, and they are not exempt from this requirement ... since the articles are new drugs ... and no approval of application ... is effective for the said articles of drugs." All of Chemicon's drugs are misbranded since the firm failed to register and list every drug in distribution, the reg letter says ....
You may also be interested in...
Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round
Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.
Cochlear’s Osia System Receives Expanded FDA Clearance For Use In Younger Children
Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.
MAISI: Navigating The 'Valley Of Death' In Medtech Research Translation
Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.