FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Proposed Rule on Wholesale Drug Distributors

[ Price : $8.95]

Federal Register notice: FDA proposes to amend certain prescription drug marketing regulations to reflect changes to affected prov...

CDRH 2022-2025 Strategic Priorities

[ Price : $8.95]

CDRH releases its strategic priorities for 2022-2025.

Drug Distributor National Standards Rule

[ Price : $8.95]

FDA proposes a rule for national standards to license wholesale drug distributors and third-party logistics providers.

11th Circuit Threatens FDA Orphan Drug Decisions: Attorneys

[ Price : $8.95]

Hogan Lovells attorneys say FDA has difficult decisions ahead to implement an 11th Circuit Court of Appeals decision against the a...

FDA Likes New User Fee Interactions, and Resources: Hearing

[ Price : $8.95]

FDA tells a House user fee reauthorization hearing that it is enthusiastic about new early interaction meetings for getting feedba...

Immunogenicity Information Guidance

[ Price : $8.95]

FDA issues a draft guidance on the content and format of immunogenicity information in therapeutic protein and select drug product...

Lilly Delays Alzheimers BLA Due to Aduhelm Debacle

[ Price : $8.95]

Eli Lilly delays a planned BLA accelerated approval submission for its Alzheimers investigational antibody therapy donanemab due t...

Biden Sets New Cancer Moonshot Goals

[ Price : $8.95]

President Biden re-launches his Cancer Moonshot with new goals and activities, including a cancer cabinet with FDA and other agenc...

OTC Drug Formal Meeting Guidance

[ Price : $8.95]

FDA issues a draft guidance on policies and procedures for formal agency meetings with sponsors or requestors of OTC monograph dru...

Attorneys See More Telehealth False Claims Cases

[ Price : $8.95]

Two Hogan Lovells attorneys see an ongoing Department of Justice interest in telehealth fraud and electronic health records cases.