FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CGMP Violations at Jiangsu NHWA

[ Price : $8.95]

FDA warns Chinas Jiangsu NHWA Pharmaceuticals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

FDA Approves 1st Modified Risk Tobacco Products

[ Price : $8.95]

FDA approves eight smokeless tobacco products under the new modified risk tobacco product pathway.

IntelGenx Resubmits NDA for Migraine Drug

[ Price : $8.95]

FDA accepts for review an IntelGenx 505(b)(2) NDA resubmission for Rizaport VersaFilm (rizatriptan ) an oral disintegrating film f...

Latest FDA Warning Letters

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that includes Jiangsu NHWA Pharmaceutical Co. and Sofie Co.

Concerns on FDA Gastroparesis Guidance

[ Price : $8.95]

Three stakeholders raise concerns with an FDA guidance on gastroparesis drug development.

FDA Breakthrough for Knee Biofilm Infection Killer

[ Price : $8.95]

FDA grants Garwood Medical a Breakthrough Device designation for its BioPrax device for eliminating biofilm infections on prosthet...

Draft Guide on Drug Master Files

[ Price : $8.95]

FDA makes available a draft guidance entitled Drug Master Files.

Lawmakers Want Answers on Takeda Natpara Recall

[ Price : $8.95]

Several lawmakers write FDA acting commissioner Ned Sharpless seeking more information about a recent Takeda Pharmaceuticals recal...

Bayer Files sNDA to Extend Mirenas Use

[ Price : $8.95]

Bayer submits a supplemental NDA to extend the duration of use for its intrauterine device Mirena (levonorgestrel-releasing intrau...