Regulatory

55 episodes

There are federal, state and local regulatory frameworks that guide the way companies and individuals in the life sciences function. It is important that professionals within the life sciences adhere to these regulations, and stay informed about ongoing changes being made in their industry.

woman holding scales and sword statue during daytime

Alzheimer’s and Snake Oil Salesmen

August 13, 2019Add comment

US Food and Drug Administration (FDA) cracks down on false claims--issuing warning letters to companies for marketing supplements as valid...

Play episode

Responding to an FDA Inspection – Part 4 (Preparing a War Room)

FDA Communications

Responding to an FDA Inspection – Part 4 (Preparing a War Room)

August 8, 2019Add comment

It is necessary for companies to prepare before an FDA inspection to ensure that they are in compliance. How should you develop a plan...

Play episode

Responding to an FDA Inspection – Part 3 (Preparing a War Room)

FDA Communications

Responding to an FDA Inspection – Part 3 (Preparing a War Room)

August 8, 2019Add comment

Companies must develop a plan to ensure that they are in compliance with FDA regulations during inspections. How should they accomplish...

Play episode

Responding to an FDA Inspection – Part 2 (FDA Findings, What the FDA Can Do)

FDA Communications

Responding to an FDA Inspection – Part 2 (FDA Findings, What the FDA Can Do)

August 8, 2019Add comment

How can you ensure readiness and compliance for FDA inspections? Join FDA regulatory attorney Darshan Kulkarni as he talks about how to...

Play episode

Responding to an FDA Inspection – Part 1 (FDA Findings, What the FDA Can Do)

FDA Communications

Responding to an FDA Inspection – Part 1 (FDA Findings, What the FDA Can Do)

August 8, 2019Add comment

How should your company prepare for FDA inspections? In this episode, FDA regulatory attorney Darshan Kulkarni discusses the steps...

Play episode

10 Ways to Communicate With the FDA

FDA Communications

10 Ways to Communicate With the FDA

August 1, 2019Add comment

[et_pb_section fb_built=”1″ _builder_version=”3.29.3″ custom_padding=”||5px|||”...

Play episode

- Listen on:
- Spotify
- Apple
- Google
- Stitcher
- iHeart Radio