Three of FDA’s Centers (CDER, CBER, and CDRH) recently published a combined draft guidance for Industry entitled Bridging for Drug-Device and Biologic-Device Combination Products (here). This draft guidance provides the FDA’s current thinking on what manufacturers should consider when they wish to bridge the data from one such combination product to another combination product during product development (IND-phase) or preparing an NDA or BLA.
Lachman Consultant Services’ Ricki Chase sees too many companies falling down on design control activities when they set out to make combination device/drug products. Check out what she said here.
Ricki Chase, Director, Lachman Consultant Services Inc. Ms. Chase is former Director of the FDA Investigations Branch, where she was responsible for all operations including inspections, investigations, sample collections, consumer complaints, import operations and emergency response programs. Ms. Chase is an expert in implementation of food and drug law, compliance law,
In a recent blog post, FDA Commissioner Scott Gottlieb reinforced FDA’s plans for supporting the growing innovation in medical technology. Dr. Gottlieb reemphasized the support for digital medical technologies through the implementation of the 21st Century Cures Act, which requires FDA to clearly define those technologies that are used for the promotion of health life choices and generally exempt from,
On May 8, 2017, the US FDA’s Center for Radiological Health announced that it will be establishing a new digital health unit under the Office of the Center Director. This is just the latest step the Agency is taking to try to keep pace with the quickly evolving and rapidly growing digital medical device industry.
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 covered issues associated with dietary supplements that contain hidden drug ingredients,
Take a look at the wrist of many individuals today and you will likely see a device monitoring physical activity. Whether it be a stand-alone device or one in the form of a watch which also facilitates telephone and text conversations, the business of personal wellness is growing. In 2014, Price Waterhouse estimated that over $200 million had been invested in wearable start-up ventures.
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 the investigator or analyst?
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 structure.
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 or regulations.