Bert Lao
Hogan Lovells
Articles
Homeopathic drug product makers warned to follow FDA premarket and GMP rules
USA - January 17 2023 Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach…
OIG audit finds lack of compliance with ClinicalTrials.gov reporting requirements from NIH studies
USA - August 23 2022 A newly released audit by the Office of Inspector General (OIG) found that for clinical trials funded by the National Institutes of Health (NIH) for…
Restrictions on Lawyer Ads Involving Drugs and Medical Devices Are Not Unconstitutional, Says Federal Court
USA - May 18 2022 The Fourth Circuit has found that a West Virginia state law restricting how attorneys can solicit clients in pharmaceutical and medical device cases…
First company receives FDA violation notice for ClinicalTrials.gov submission omission
USA - April 29 2021 On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required…
Robert Church, Heidi Gertner, David Horowitz, Blake E. Wilson
HHS now requires public posting of a decade of clinical trial results that were previously exempted
USA - August 11 2020 Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies…
