FDA Law Blog

NOVEMBER 16, 2021

Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. In the pre-market area, Ms. In the post-market area, Ms. Prior to joining the Firm, Ms. In addition, Ms.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. What is the scope of the Guidance? Companies can sponsor website content if the role of the company is made clear.

Life Science 86

Life Science Compliance Regulation Cosmetics 86

Advarra

SEPTEMBER 23, 2022

Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . When Does an IND go into Effect? .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52