article thumbnail

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

The FDA Law Blog

Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA.

FDA 144
article thumbnail

Reports Document FDA Review Delays: What Drugmakers Should Know Now

The FDA Law Blog

Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. Thats all bad news if your timeline depends on FDA sticking to theirs. By John W.M. Claud & Michelle L.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA sends warning letter to KVK-Tech manufacturing facility

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has sent a warning letter to KVK-Techs drug manufacturing facility following an inspection in April 2019. The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Whats next for KVK-Tech?

FDA 88
article thumbnail

STAT+: Top FDA officials weighing regulation of ultra-processed foods, internal documents show

STAT

Two FDA officials, Haider Warraich and Robin McKinnon, met multiple times in February to discuss regulating these edible industrial creations, such as sodas, prepackaged cookies, and most breakfast cereals. Warraich serves as a senior adviser to FDA commissioner Robert Califf. Continue to STAT+ to read the full story…

article thumbnail

Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection

Fierce Pharma

From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.

article thumbnail

STAT+: Brain biopsies on ‘vulnerable’ patients at Mount Sinai set off alarm bells at FDA, documents show

STAT

In study documents, Mount Sinai doctors said the biopsies result in “the same amount of tissue loss” and “in effect, the same level of risk” for patients as standard DBS, because they are removing tissue that would otherwise be cauterized.

article thumbnail

Is the FDA headed for a major reorganization?

PharmaVoice

A leaked document revealed details about changes that could impact how the agency operates, but recent comments from FDA Commissioner Dr. Marty Makary have muddied the picture.

FDA 148