Profile cover photo
Profile photo
Track Regulatory
37 followers -
Track Regulatory Blog...
Track Regulatory Blog...

37 followers
About
Posts

Post has attachment
USFDA CBER - Annual Summary for Fiscal Year 2014
Center for Biologic Evaluation and Research at USFDA has released its Annnual Summary Report for the Fiscal Year 2014. FDA requires reporting of certain deviations and unexpected events in manufacturing in accordance with 21 CFR 600.14, 606.171 or 1271.350(...
Add a comment...

Post has attachment
USFDA: New and Generic Drug Approvals: 30 MAR 2015
New and Generic Drug Approvals March 30, 2015 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Aceon perindopril erbumine Tablet;Oral Symplmed Pharms Llc Labeling Revision Advil Congestion Relief ibuprofen; phenylephrine hydrochloride T...
Add a comment...

Post has attachment
New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
Innovation drives progress. When it comes to innovation in the
development of new drugs and therapeutic biological products, FDA’s
Center for Drug Evaluation and Research (CDER) supports the
pharmaceutical industry at every step of the process. With its ...
Add a comment...

Post has attachment
UK MHRA - Medical device alert
Hudson RCI© humidifier adaptors and Aquapak sterile water with humidifier adaptors - risk of inhaling plastic pieces (Teleflex Medical) Some packages contain pieces of plastic that
could get into the gas flow path and enter the lungs (MDA/2015/015). For fu...
UK MHRA - Medical device alert
UK MHRA - Medical device alert
trackregulatory.blogspot.com
Add a comment...

Post has attachment
USFDA CDRH - List of Medical Devices Cleared/Approved in the 2014...
2014 Device Approvals The products listed in this section include some of the newest
medical technology from the year 2014. The products in each list contain
information about what medical uses the device is cleared or approved
for, when it can be used, ...
Add a comment...

Post has attachment
USFDA : Guidance for Industry - Critical Path Innovation Meetings...
Today, the U.S. Food and Drug Administration released a draft guidance: “ Procedures for Meetings of the Medical Devices Advisory Committee .”   Advisory
committees play an important role in the FDA’s regulation of medical
devices by providing independent...
Add a comment...

Post has attachment
USFDA: New and Generic Drug Approvals: 27 MAR 2015
New and Generic Drug Approvals March 27, 2015 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Amturnide aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide Tablet;Oral Novartis Labeling Revision Aptivus tipranavir Capsule;...
Add a comment...

Post has attachment
USFDA: New and Generic Drug Approvals: 25 NOV 2014
New and Generic Drug Approvals November 25, 2014 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Amoxil amoxicillin For Suspension;Oral Dr Reddys Labs Inc Labeling Revision Bupropion Hydrochloride bupropion hydrochloride Tablet, Extend...
Add a comment...

Post has attachment
USFDA: New and Generic Drug Approvals: 24 NOV 2014
New and Generic Drug Approvals November 24, 2014 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Acanya benzoyl peroxide; clindamycin phosphate Gel;Topical Dow Pharm Efficacy Supplement with Clinical Data to Support Byetta exenatide sy...
Add a comment...

Post has attachment
USFDA: New and Generic Drug Approvals: 21 NOV 2014
New and Generic Drug Approvals November 21, 2014 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Adcetris brentuximab vedotin Injectable; Injection Seattle Genetics Labeling Revision Cardizem diltiazem hydrochloride Tablet;Oral Valeant...
Add a comment...
Wait while more posts are being loaded