RAPS Highlights





12 August 2022 | By Michael Mezher
This Week at FDA: Amazon warning letter, ANDA amendments, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device...

12 August 2022 | By Joanne S. Eglovitch
Expert: OGD on track to approve more generic drugs in FY2022

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) will most likely approve a higher number of generic drugs ...

12 August 2022 | By Louise T. Göttsche, MSc, MBA
The value of a ready-to-use therapeutic food guideline for severe malnutrition

Ready-to-use therapeutic foods (RUTFs) are used in the treatment of children with severe acute malnutrition (SAM) without medical co...

11 August 2022 | By Joanne S. Eglovitch
FDA blasts California firm for multiple GLP issues involving nonclinical studies

The US Food and Drug Administration (FDA) found a slew of good laboratory practice (GLP) violations during the conduct of nonclinica...

11 August 2022 | By Joanne S. Eglovitch
Recon: PhRMA weighs legal options as US pricing reforms move through Congress; Europe to consider dose-sparing to increase monkeypox vaccine

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.