Bert Lao

Bert Lao

Hogan Lovells

Contact
View Bio
RSS

Latest Posts › Draft Guidance

Share:

Homeopathic drug product makers warned to follow FDA premarket and GMP rules

Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against homeopathic products that it...more

1/17/2023  /  CARES Act , CGMP , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , GRAS , Homeopathic Remedies , Manufacturers , Over The Counter Drugs (OTC)

Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank." ...more

9/26/2018  /  Civil Monetary Penalty , Clinical Trials , Disclosure Requirements , Draft Guidance , Food and Drug Administration (FDA) , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical...

On 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 — Questions and Answers." The draft guidance is...more

6/28/2017  /  Cloud Computing , Data Protection , Draft Guidance , E-Signatures , Electronic Medical Records , Food and Drug Administration (FDA) , Mobile Device Management
3 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