10
Aug
Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients Image

Dietary Supplement Manufacturers, Are You Ready for FDA?

The dietary supplement industry has been burgeoning since the 1990’s when the number of products on the US market was approximately 4,000. In 2015, the journal Drug Testing and Analysis estimated the number of US manufacturers to be approximately 15,000, accounting for more than 90,000 products and a $40-billion-dollar industry.  The Lachman blog has extensively […]

Read More
13
Jul

FDA SUPPORTS SHARING FEEDBACK ON INVESTIGATOR CONDUCT DURING INSPECTIONS

If you work in regulated industry, you will eventually be inspected by the Food and Drug Administration (FDA).  With each inspection comes an opportunity to forge good working relationships with the individuals on the forefront of your compliance status.  With so much riding on any given inspection, what do you do if problems arise with […]

Read More
06
Jul
FDA’s Program Alignment: More Questions Than Answers Image

FDA’s Program Alignment: More Questions Than Answers

In February 2014, then FDA Commissioner Margaret Hamburg issued a memorandum directing all Centers and the Office of Regulatory Affairs (ORA) to develop a plan for more collaboration and efficiency in operations.  As a result of this mandate, the Centers and ORA have developed fiscal year plans to move toward a distinct commodity-based, vertically-integrated regulatory […]

Read More
29
Jun
What’s the Delay, FDA Image

What’s the Delay, FDA?

As a group of consultants to domestic and international pharmaceutical companies, we work with many clients responding to inspectional findings from an FDA inspection.  At the close of the inspection, an FDA-483, Inspectional Observations form, may be issued to the firm’s management outlining conditions, which the FDA investigator(s) believe may constitute deviations from applicable law […]

Read More
1 2