Several leading drugmakers — including Janssen, Novo Nordisk and Genentech — urged the FDA to include new information on interchangeable products in the agency’s Purple Book, which lists biological products…
In new draft guidance issued Friday, the FDA outlined what it expects sponsors to include in submissions of use-related risk analyses, threshold analyses, comparative use human factors (HF) and HF…
The FDA Friday issued two new draft guidances — one on adaptive clinical trials and the other on master protocol designs — that it hopes will help sponsors innovate and…
A newly unsealed lawsuit accuses AstraZeneca of using nurses to covertly promote its products, echoing a similar complaint against AbbVie. Source: Drug Industry Daily
Mylan and Novartis criticized the FDA’s use of arbitrary suffixes in a non-proprietary naming convention for biologics in comments about a Sept. 4 a public hearing aimed at promoting biosimilars…
White House-backed measures to prohibit pharmacy “gag clauses” are poised to become law after the House unanimously approved them Tuesday. Source: Drug Industry Daily
Symed Labs was hit with a Form 483 after an FDA inspection of its Hyderabad, Telangana facility revealed equipment cleaning and complaint handling violations. Source: Drug Industry Daily
The FDA slapped Phoenix-based outsourcing facility Atlas Pharmaceuticals with a warning letter for adulterated and misbranded drug products as well as numerous CGMP violations stemming from an inspection carried out…
Prices increased for 4,400 branded drugs and were cut for only 50 this year, a new study found. Source: Drug Industry Daily
House and Senate conferees reached agreement late Tuesday on a final version of an expansive legislative package to address the opioid crisis. Source: Drug Industry Daily