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The European Commission will revise four sections of its good manufacturing practice guideline and add a new one, as it moves to harmonize GMPs with international standards and speed the path to mutual reliance with foreign regulators, a UK official says. Read More
The U.S. Food and Drug Administration expects to boost its China office staff to 35 within the next two years and its India staff to 23 as the agency focuses on increasing inspections in both countries. Read More
India’s national drugs authority will hire 147 inspectors this year to ensure adherence to good manufacturing practices, but training will determine success, an observer says. Read More
The FDA is requiring stronger label warnings for non-aspirin nonsteroidal anti-inflammatory drugs, after a comprehensive review of new safety information affirmed an increased risk of heart attack or stroke. Read More
The House of Representatives Friday approved the 21st Century Cures Act by a vote of 344 to 77, moving focus to the Senate where efforts have begun to develop comparable legislation. Read More
Manufacturers may obtain marketing authorization based on less-than-comprehensive applications if they supplement their filings with clinical data. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More