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Patient-Focused Meeting on Alpha-1 Antitrypsin Deficiency

06/01/2015

Federal Register Notice: FDA will hold a public meeting 9/29 on Patient-Focused Drug Development for Alpha-1 Antitrypsin Deficienc...

Rectal Control System into Class 2

06/01/2015

Federal Register Final order: FDA is classifying the rectal control system into Class 2 (special controls). The special controls a...

Grant Funds Available for Multiple Myeloma Study in Black Patients

05/28/2015

Federal Register Notice: FDA is announcing the availability of grant funds for supporting the efforts of CDER. The agency intends ...

Guidance on Mutagenic Impurities in Pharmaceuticals

05/28/2015

Federal Register Notice: FDA is making available a guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impurit...

Pediatric Study Report Available for Meropenem

05/28/2015

Federal Register Notice: FDA is publishing a summary report of the pediatric studies of meropenem conducted in accordance with the...

Vibrator into Class 2

05/28/2015

Federal Register Final order: FDA is classifying the vibrator for climax control of premature ejaculation into Class 2 (special co...

Comments Period Extended on Radiation Biodosimetry Device Guidance

05/28/2015

Federal Register Notice: FDA is reopening the comment period until 6/29 the notice of availability entitled “Radiation Biodo...

Grant Funds Available to Support ICH

05/18/2015

Federal Register Notice: FDA is making available grant funds for supporting the International Council for Harmonization of Technic...

FDA Makes Recommendations for Study Data Plans

05/18/2015

Federal Register Notice: FDA is making available draft recommendations for preparing a Study Data Standardization Plan. It is refe...

Guidance on Device Adaptive Clinical Study Designs

05/18/2015

Federal Register Notice: FDA is making available a draft guidance entitled Adaptive Designs for Medical Device Clinical Studies; D...