FDA Law Blog
JANUARY 29, 2023
Evans* — A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification.
The Crime Report
AUGUST 24, 2021
Despite some collaborative improvements, Chinese regulatory authorities delay requests for access to inspect and investigate potential sites where companies illegally manufacture precursor chemicals that Mexican and other foreign drug cartels use to produce fentanyl.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
JANUARY 1, 2024
Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.
ClimateChange-ClimateLaw
JUNE 27, 2023
For a small-scale renewable energy project, a municipality may be able to rely on minimal legal assistance. Slightly more complex are the ITC and PTC, for which a project developer (local governments included) have to choose only one.
InHouseOps
MAY 23, 2022
Yet, they don’t always feel empowered to advocate for the tools they need, even when having these tools will save time, reduce risk and even lower the company’s legal spend. How will this project support their objectives to lower the company’s legal risk profile, as well as reduce the expenses of the legal department?
ClimateChange-ClimateLaw
APRIL 9, 2021
The appellate court agreed with the OAG that redacted portions of the application were privileged as “preliminary communications made between a client and its prospective counsel while seeking legal assistance.” The redacted sections were therefore exempt from disclosure due to attorney-client privilege. Frosh , No. 2ndd (Md.
Expert insights. Personalized for you.
59 
Let's personalize your content