Countries Manufacturing Pharmaceuticals for the US Market: A 10-Year Analysis of Public Data.

Background: Concerns about strategic supplies and quality have increased the scrutiny of the countries where US pharmaceuticals are made.

Objective: To examine the locations of manufacturers of brand name, biological, and generic drugs over 10 years.

Methods: This longitudinal descriptive study used publicly available data from US government Web sites, including the Food and Drug Administration (FDA) Drug Establishments list, FDA National Drug Code Directory, FDA Orange Book, FDA Purple Book, and the National Institutes of Health DailyMed Drug Labels.

Site-Specific and Country-of-Origin Labeling for Pharmaceutical Manufacturing.

There is increasing concern about the quality of pharmaceuticals, especially generics made in Asia. Popular books and news reports have the public questioning the quality of pharmaceuticals. Recalls and import bans shake confidence in medications, particularly for active pharmaceutical ingredients and finished dosage forms made outside the United States.

Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data.

Background: Although outcomes data on transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (Mitraclip) are available via the Transcatheter Valve Therapy (TVT) registry, dissemination of TVT data is often delayed. The Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) system collects postmarket outcomes data in public medical device reports. We used natural language processing to compare the event rates for TAVR and Mitraclip in the TVT registry and from MAUDE data.