The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how firms in a distribution chain can prepare when conducting a voluntary recall. The guidance includes nonbinding recommendations and explicitly does not establish legally enforceable … Continue Reading
Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Food & Health Care Industries.
Some important developments during June include:
- Chinese drug company to build production and training center in U.S.
- Drug company challenged for environmental contamination in China
- China's national biomedical plan to be released soon
- Issuance of administrative measures for device recalls
- Designation of four professional associations to examine Class III medical technology
- Extension of Drug GMP certificates
- Recall of an antibiotic… Continue Reading
Recent events highlight the importance of having a plan for product recalls. The Food and Drug Law Institute's recent monograph entitled, "International Prescription Product Recalls: A Practical Guide, Volume 1, Number 4," provides comprehensive guidance and practical recommendations on dealing with recalls internationally as well as a checklist and valuable "dos and don'ts" for manufacturers facing product recalls. Written by Reed Smith partners James M. Wood and Areta L. Kupchyk, the publication is available for download by series and individual issue subscribers.
For more information or to order, see www.fdli.org.… Continue Reading
It seems like a rare day when there is not a notice of a foreign-made defective product being recalled in the United States. In recent months, there have been more than 500 recalls of a variety of products including millions of toys coated with lead paint, thousands of illegal fireworks, contaminated meats, and tainted medicines. … Continue Reading