FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Product Design Safety Consideration Draft Guidance Out

[ Price : $8.95]

FDA publishes a draft guidance to help drug sponsors minimize medication errors relating to drug product design.

Mylan Wants FDA to Deny Valeant Zovirax Petition

[ Price : $8.95]

Mylan calls on FDA to deny a Valeant petition asking that the agency require clinical endpoint studies for any ANDA for generic Zo...

Milo Biotech Orphan Status for Muscular Dystrophy Drug

[ Price : $8.95]

FDA grants Milo Biotechnology an orphan drug designation for AAV1-FS344 for treating Becker and Duchenne muscular dystrophy.

OMB OKs Info on Disease Info in Branded Promos

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on an experimental study on...

Guidance for Home Use Device Design

[ Price : $8.95]

FDA publishes a draft guidance to help manufacturers design and develop home use medical devices that minimize their unique risks.

Orphan Status for Diffusion Pharma Brain Cancer Therapy

[ Price : $8.95]

FDA grants Diffusion Pharmaceuticals an Orphan Drug designation for trans sodium crocetinate and its use in treating metastatic br...

Multiple QS Violations Found at Parks Medical Electronics

[ Price : $8.95]

FDAs Seattle District Office warns Parks Medical Electronics about multiple Quality System violations at its facility manufacturin...

Drug Sponsors Shun Biosimilars Pathway: FDA

[ Price : $8.95]

CDER associate director for biosimilars Leah Christl says biosimilar product developers have essentially ignored FDAs abbreviated ...

Roxane Wants Jazz Xyrem Petition Denied

[ Price : $8.95]

Roxane tells FDA it should deny Jazz Pharmaceuticals latest citizen petition seeking to delay review of any ANDAs for generic Xyre...

Senators Want Medical Device Tax Delayed

[ Price : $8.95]

AdvaMed praises a call by 18 senators for a delay in implementation of the upcoming medical device tax.