The Lachman Blog

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13
Sep

Court Reverses Itself on NCE Issue-What Happens to ANDAs Already Received?

In a stunning reversal of opinion on the issue of FDA’s failure to award new chemical entity (NCE) exclusivity to the drug Prepopik, the world of NCE awards and ANDA acceptance for receipt for fixed dose combination (FDC) products that contain a first-time approved active ingredient may be turned on its head.  This was discussed […]

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12
Sep

FDA Updates List of Guidance Documents It Plans to Issue in 2016

The FDA announced some additions (**) and revisions to titles (*) of Guidance documents it plans to release in 2016.  We have posted on this list previously (here) (and here) and highlighted this blogger’s impression of some of those proposed Guidance documents.  Well, FDA has published another revised list and here are the changes: Comparative […]

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02
Sep

19 Consumer Antiseptic Wash Ingredients Found Not to Be GRAS/GRAE

The FDA published a Federal Register (FR) notice today declaring that 19 ingredients for use in consumer antiseptic wash (use with water to wash off) are not generally recognized as safe and effective (GRAS/GRAE).  The Agency has however deferred a decision on three additional ingredients (benzalkonium chloride, benzethonium chloride, and chloroxylenol) for this use as […]

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31
Aug

Opioids and Benzodiazepines to Get FDA’s Strongest Warning

The FDA announced in a safety warning today (here) that it was adding a Black Box Warning on all opioid and benzodiazepine products due to continued concern relative to potential fatal interactions and severe adverse events.  The warning notes that the “FDA review has found that the growing combined use of opioid medicines with benzodiazepines […]

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30
Aug

202 Page FR Notice – Final Rule for Revised Drug Listing and Manufacturers Registration, Take Note!

Have some spare time on your hands?  Read the new Final Rule that FDA pre-published today (here) .  FDA says the rule, to become effective 90 days after final publication in the Federal Register (FR), is designed to modernize the drug and establishment listing requirements of sections 207 and 607, and to bring them in […]

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