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
The FDA issued final guidance Tuesday for outsourcing facilities on compounding and repackaging radiopharmaceuticals, along with draft guidance on insanitary conditions at compounding facilities. Source: Drug Industry Daily
The FDA issued a warning letter to Wilson Medicine Company citing serious quality problems found during a Feb. 26-March 1 inspection of its OTC manufacturing facility in Nandore, India. Source:…
The EMA lowered its estimate for the number of centrally authorized drugs that may face post-Brexit supply disruptions from 108 to 39 — including 25 human medicines. Source: Drug Industry…
Against a backdrop of declining sales for its branded hepatitis drugs, Gilead announced plans to launch its own “authorized generics” of two of its hep C treatments. Source: Drug Industry…