News & Analysis as of

Pharmaceutical Industry › Food and Drug Administration (FDA) › Over The Counter Derivatives (OTC)

Sheppard Mullin Richter & Hampton LLP

FDA Revisits and Updates Guidance on Addressing Misinformation – Ten Years Later

Sheppard Mullin Richter & Hampton LLP on

On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Approach to Pediatric Drug Development

Sheppard Mullin Richter & Hampton LLP on

On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of pediatric drug development — “Regulatory...more

Sheppard Mullin Richter & Hampton LLP

FDA Appointment Signals Increased Attention on Medical Device Cybersecurity

Sheppard Mullin Richter & Hampton LLP on

At the beginning of February, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) appointed Professor Kevin Fu as the first ever Acting Director of Medical Device Cybersecurity. Fu’s...more

Mintz - Health Care Viewpoints

Medical Products & FDA: What to Watch for in 2019

Mintz - Health Care Viewpoints on

Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar...more

Hogan Lovells

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

Hogan Lovells on

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good...more

Holland & Knight LLP

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

Holland & Knight LLP on

On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more

Hogan Lovells

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

Hogan Lovells on

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. ...more

7 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide