Keeping TRACK - FDA offers a look at the upcoming rulemakings

31 March 2016

As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules.

By 31 March, according to the TRACK database, the agency expects to release four final rules and three proposed rules pertaining to FDA’s regulation of drugs, devices, food and compounded drugs, including:

  • A final rule to allow for stand-alone symbols on device labels that are established as part of a standard developed by a national or international standards development organization, provided that the symbols are explained in a glossary included in the labeling. The rule also revises prescription device labeling regulations to authorize the use of the symbol statement "Rx only" on the labeling of prescription devices.
  • A proposed list of bulk drug substances that may be used to compound drug products, as well as criteria for evaluating bulk drug substances for inclusion on the list.
  • A proposed rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients, which is the result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts to reduce unnecessary duplication and differences.

Later in 2016

Sometime in April, FDA says it will release a final rule describing new postmarketing safety reporting requirements for combination products (combinations of a drug, device and/or biologic).

“The rule would clarify that a combination product is subject to the reporting requirements associated with the type of marketing application under which the product is approved, licensed, or cleared, and to certain additional, specified reporting requirements depending on the types of constituent parts (drug, device, or biological product) of which it is comprised,” FDA says. “The regulation would ensure the consistency and appropriateness of postmarket safety reporting for combination products while minimizing duplicative reporting requirements.”

In addition, FDA also expects to release a new proposed rule setting the minimum current good manufacturing practice (cGMP) requirements for human drug products compounded by an outsourcing facility

And for the home-based medical device market, sometime in May, the agency is seeking to require certain medical device establishments listing home-use medical devices to submit, in electronic format, the label and package insert of certain devices listed with FDA. The agency says it intends to make the information from the submitted labeling publicly accessible online.

In July, FDA is expected to release a proposed rule that would establish special controls for the computed tomography (CT) X-ray system. FDA is establishing proposed special controls, which are necessary to provide reasonable assurance of the safety and effectiveness of a Class II CT X-ray system.

“High doses of ionizing radiation can cause acute (deterministic) effects such as burns, reddening of the skin, cataracts, hair loss, sterility, and, in extremely high doses, radiation poisoning,” FDA says. “The design of a CT X-ray system should balance the benefits of the device (i.e., the ability of the device to produce a diagnostic quality image) with the known risks (e.g., exposure to ionizing radiation).” 

Also in July, FDA expects to release a major generic drug labeling rule that would allow generic companies to update their labels with new safety information like their reference product counterparts have done for almost 30 years.

And a proposed rule to require electronic package inserts for drugs and biologics with limited exceptions, in lieu of paper, is also being proposed for release sometime in October 2016. These inserts will contain prescribing information intended for healthcare practitioners and aim to provide the most up-to-date information regarding safety and efficacy issues.

Unified Agenda-TRACK

Source: RAPS