FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Bill on Compounding Oversight Introduced

[ Price : $8.95]

Reps. DeLauro and Lowey introduce legislation to strengthen regulation of compounding pharmacies.

CDRH Mobile Apps Final Guidance Close

[ Price : $8.95]

CDRHs final guidance is close to being published, Center policy advisor Bakul Patel tells an industry meeting during a broad-rangi...

Criticism of FDA Can Lead to Lack of Innovation: Woodcock

[ Price : $8.95]

CDER director Janet Woodcock says external pressures on FDA can lead to a feeling among staff that they should pursue traditional ...

Small Business Guidance on OTC Sunscreen Product

[ Price : $8.95]

Federal Register Notice: FDA releases a compliance guidance for small businesses on labeling and effectiveness testing for OTC sun...

Multiple Sclerosis Outcome Assessments Consortium Formed

[ Price : $8.95]

Groups form consortium to develop endpoints for multiple sclerosis trials.

CDRH Officials Address Diabetes Patients on Agency Slowness

[ Price : $8.95]

In an unprecedented move, three CDRH officials address review/approval slowness on a diabetes patient blog.

FDA Says Heparin Product Labeling Changing

[ Price : $8.95]

FDA says labels for two heparin products will change to list the strength of the entire container of the medication and how much o...

Trimel Plan NDA for Testosterone Replacement Therapy

[ Price : $8.95]

Trimel Pharmaceuticals says it is preparing an NDA for CompleoTRT (testosterone) for use as a replacement therapy.

FDA OKs Lipocine Phase 3 Trial for Testosterone Replacement

[ Price : $8.95]

FDA clears a Lipocine Phase 3 study of its oral testosterone replacement therapy.

Guidance on Limiting Phthalates as Excipients in Drugs/Biologics

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products.