Congress Finds Interest in Foreign Inspection Postponements Due to the Pandemic

In March 2020, the FDA postponed all inspections of domestic and foreign drug manufacturing facilities due to the COVID-19 pandemic.  However, drug products manufactured overseas are still entering the U.S. market, prompting some U.S. Senators to voice their concern.  On November 10th, two members of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent […]

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Even In the Face of COVID 19, the Beat Still Goes On

Although though we are in the grips of a pandemic and our attention is focused on the development of treatments and vaccines for COVID-19, manufacturing of drug products to treat other conditions is continuing, and GMPs must still be maintained. Sponsor companies continue to manufacture products and are still dependent upon products and services from […]

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Ranitidine Market Withdrawal Mandated by FDA

These days, everybody’s attention is focused is focused on COVID-19.  However, that does not mean that the issues that the FDA was struggling with prior to the pandemic have disappeared.  In fact, some rather major news regarding nitrosamine impurities was announced by the FDA yesterday (and it wasn’t an April Fools’ Day stunt!). Yesterday, the […]

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Will the Crunch Be On?

On Tuesday March 24, 2020, Prime Minister Narenda Modi of India ordered an extensive lockdown of all of its 1.3 billion residents.  “There will be a total ban of coming out of your homes,’’ Mr. Modi said. “Every district, every lane, every village will be under lockdown,’’ he said.  “If you can’t handle these 21 […]

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FDA’s Warning Letter Database – Has Any Progress Been Made Since the FDA Website Update?

Some time ago, we highlighted the issues that we had been facing searching FDA’s Warning Letter database in the new FDA website (FDA’s Website Re-Design – Did Something Get Left Behind?).  We wanted to give you an update as to where the current status of this is. Since drafting this post, we received some email […]

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FDA’s Website Re-Design – Did Something Get Left Behind?

For those of us in the regulated industry, we rely on FDA’s website for many different things. FDA.gov has historically been not the most intuitive website, with all of the Centers running their own pages, and inconsistencies occurring as a result of having many “chefs in the kitchen”, as the saying goes. On April 26, […]

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