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Protecting the Public Health Trumps Explicit Legislative Mandate, FDA’s Chief Counsel Tells FDLI

FDA’s mandate to protect the public health requires making decisions in situations where there is no law explicitly empowering it to act, FDA Chief Counsel Ralph Tyler stressed at the Food and Drug Law Institute (FDLI) Annual Meeting in late April. In turn, Tyler explained that a key role for FDA lawyers is to be advocates for the agency in helping it reach its policy and enforcement goals in situations where waiting for approval from Congress does not allow a timely enough decision....

FDA to Partner with State Agencies on Recalls and Regulatory Actions

FDA is developing national procedures for engaging state agencies in the follow-up to recalls and moving toward partnerships with state agencies to allow the use of state data to support other regulatory actions....

McNeil Voluntary Plant Shutdown, Product Recalls Follow FDA Inspection

On April 30, McNeil Consumer Healthcare, the OTC division of J & J, announced a recall of about 1,500 lots of liquid infant’s and children’s Tylenol, Motrin, Zyrtec and Benadryl, and voluntarily shut down the plant where they were manufactured at the end of a two-week FDA inspection at their Fort Washington, PA facility....

Propofol Shortage Follows Teva and Hospira Warning Letters and Recalls

European manufacturer Fresnius is stepping in to help fill the US shortage in the injectible anaesthetic propofol caused by GMP problems at Teva and Hospira, resulting in warning letters and recalls. FDA's lengthy warning letter to TEVA in December, posted in April, focused on the manufacture of their generic version of propofol, and primarily related to microbial contamination and testing, including endotoxin in distributed product....

IPQ Special Report — May/June 2009

ANALYSIS OF FDA AND EU GMP ENFORCEMENT ACTIVITY shows inadequate investigation of manufacturing and product nonconformances to be the most pressing concern on both sides of the Atlantic. FDA warning letters and injunctions are frequently linking GMP problems with the manufacturing of products that do not have the required new drug approval or do not […]
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