FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Topical Ophthalmic Quality Guidance

[ Price : $8.95]

Federal Register notice: FDA releases a draft guidance entitled Quality Considerations for Topical Ophthalmic Drug Products.

Info Collection on Recall Regulations

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Recall Regulations 21 CFR Part 7....

Canadian Drug Importation: Information Collection

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Importation of Prescription Drugs from Cana...

InfoBionic Next-Gen Cardiac Monitor

[ Price : $8.95]

FDA clears an InfoBionic 510(k) for its MoMe ARC, the companys third-generation remote electrocardiogram monitoring device.

Heidelberg Engineering Ocular Platform Cleared

[ Price : $8.95]

FDA clears a Heidelberg Engineering 510(k) for its ANTERION platform, which the company says is designed to transform anterior seg...

FDA to Study Adherence Effect on Promotion

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion says it plans to research adherence potential and patient preference in prescriptio...

Topical Ophthalmic Drug Quality Guidance

[ Price : $8.95]

FDA publishes a draft guidance on quality considerations for ophthalmic drug products indicated for topical delivery in and around...

Stelara Biosimilar Gets Complete Response

[ Price : $8.95]

Citing inspection findings that need to be resolved, FDA sends Alvotech a complete response letter for its BLA for AVT04, a biosim...

Mekinist Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Novartis Pharmaceuticals Mekinist (trametinib dimethyl sulfoxide) tablets (1 mg) were...

Info Collection on Regulatory Misconduct Allegations

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Allegations of Regulatory Misconduct Volunt...