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 conformance with section 510 of the Federal Food,

Follow-up on PIC/S Data Integrity Guidance

We recently posted an overall summary of the new draft PIC/S Data Integrity Guidance document (here). While this valuable Guidance document covers much of the same ground as previous Data Integrity Guidance documents from other regulatory agencies, it is particularly noteworthy that in several areas it provides detailed practical requirements heretofore never provided in a regulatory agency Guidance document.

PIC/S Draft Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments”

 It is critical during the inspection process that FDA inspectors can determine the veracity of the data that is presented to them. The draft Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” dated August 10, 2016, provides inspectors detailed instructions on how to verify the integrity of the data during inspection by ensuring the data is “…complete,

Dietary Supplements Back in the News with FDA Issuance of New Draft Guidance

There has been a spate of blog posts on our site regarding dietary supplements and yet again today we are addressing a newly issued revised draft Guidance, entitled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (here).  FDA notes that, under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.

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 covered issues associated with dietary supplements that contain hidden drug ingredients,

OTC Monograph User-Fee Comment Period Extended – Look at Comments So Far

In a pre-publication Federal Register Notice on Friday, August 5, 2016, FDA announced the reopening of the comment period on the issue of OTC Monograph User fees until October 6, 2016.  In addition, the Notice indicated that the FDA “will hold a Webinar for stakeholders on September 6, 2016.  This Webinar is intended to be a follow-up to the June 10,

CDRH Releases “General Wellness: Policy for Low Risk Devices”

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. 

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 the investigator or analyst?

Additional Guidance for Compounders of Commercially Available Copies of Products

Yesterday, FDA issued two draft Guidance documents that address the compounding of essentially commercially available drug products.  The two documents, one for compounding pharmacies under Section 503A of the Act (here) and the other that addresses outsourcing facilities under Section 503B of the Act (here) describe FDA’s view of how the issue of compounding essentially commercially available drug products will be evaluated under the Act and when such products might be subject to FDA enforcement action. 

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 structure. 

Current FDA Shortage List Still Heavy on Injectable Products

 

FDA’s drug shortage list has a total of 60 drug products in the “currently in shortage” status (see list here). As you can see from the table below, injectable products are leading the list with 46 drug products currently in shortage.

The second leading category are solid oral dosage forms and then just a few other dosage forms occupy the list as still in a shortage situation.

Proposed Rule Issued Based on Tentative Final Monograph for Waterless Hand Rubs for Consumers

The Proposed Rule based on the Tentative Final Monograph (TFM) (here) is a 101-page monster that addresses consumer-type hand rubs that are designed to be used without water – generally, what one might think of as “hand sanitizers” (or “consumer antiseptic rubs” as the FDA terms them).  The Proposed Rule DOES NOT cover “OTC consumer antiseptic washes and OTC antiseptics intended for use by health care professionals in a hospital setting or other health care situation outside the hospital are GRAS/GRAE.”

In the document,