FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Workshop on Software Precertification Program

[ Price : $8.95]

Federal Register notice: FDA announces a 1/30-31/2018 public workshop entitled Fostering Digital Health Innovation: Developing the...

Comments Sought on Oncology Center of Excellence Functions

[ Price : $8.95]

Federal Register notice: FDA announces a 3/15/2018 public meeting entitled Oncology Center of Excellence: Listening Session.

Mylan Petitions FDA for Strict Bioequivalence on Advair Generics

[ Price : $8.95]

Mylan petitions FDA to require strict bioequivalence study designs for ANDA applicants seeking to market generic versions of Glaxo...

Sen. Warren Seeks $5B Funding/Research Boost for FDA and NIH

[ Price : $8.95]

Senator Elizabeth Warren (D-MA) introduces the National Biomedical Research Act that would increase funding for targeted biomedica...

Comments Sought on User Fee Performance Assessment

[ Price : $8.95]

Federal Register notice: FDA seeks comments on a statement of work to assess current practices when communicating during IND devel...

FDA Posts Annual Report on Postmarketing Study Requirements

[ Price : $8.95]

Federal Register notice: FDA posts its annual report on the status of drug/biologic postmarketing requirements and postmarketing c...

FDA Clears Genea Biomedx Benchtop Incubator

[ Price : $8.95]

FDA clears a Genea Biomedx 510(k) for its benchtop incubator Geri.

WLF Urges FDA to Replace Guidances with Rulemaking

[ Price : $8.95]

The Washington Legal Foundation urges FDA to replace all older guidances with formal regulations that undergo a notice-and-comment...

Comment Period Extended on Synthetic Peptide Guide

[ Price : $8.95]

Federal Register notice: FDA extends the comment period on a 10/3 draft guidance entitled ANDAs for Certain Highly Purified Synthe...

FDA Expands Digital Health Efforts: Gottlieb

[ Price : $8.95]

FDA commissioner Scott Gottlieb announces three new guidances to expand the agencys digital health efforts under the 21st Century ...