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# Gottlieb Sets 2018 FDA Goals
- URL: https://www.fdaweb.com/gottlieb-sets-2018-fda-goals/
- Published: 2017-12-14T12:00:00.000Z
- Updated: 2026-09-14T23:08:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140355

FDA commissioner **Scott Gottlieb** says the agency’s 2018 policy goals include regulatory changes for drugs and medical devices. Writing in an *FDA Voice* online blog [post](https://blogs.fda.gov/fdavoice/index.php/2017/12/looking-ahead-some-of-fdas-major-policy-goals-for-2018/?utm%5Fcampaign=FDA%20Voice%20Looking%20ahead%3A%20Some%20of%20FDA%E2%80%99s%20major%20policy%20goals%20for%202018&utm%5Fmedium=email&utm%5Fsource=Eloqua), Gottlieb says the agency will issue several regulations on drug compounding to help ensure the quality of medicines that patients need. “We want to make sure that outsourcing facilities clearly understand which drugs they may compound and allow these firms to adopt more streamlined manufacturing standards, while ensuring they observe necessary safety and quality measures,” he writes.

The agency also will issue a proposed rule to establish national standards for licensing prescription drug wholesale distributors and third-party logistics providers as part of its track-and-trace requirements.

As part of a broader effort to empower consumers, Gottlieb says, there will be a rulemaking proposing a new type of medical document that would help ensure that patients have access to clear, concise and useful written information about their prescription drugs or biologics, delivered in a consistent and easily understood format, each time they receive a medication from the pharmacy.

FDA also is considering “innovative action in the nonprescription drug area to expand the scope of drug products that can be made available to consumers without a prescription.”

Efforts to ensure that standards and regulations are modern and reflect the latest science and have not become outdated, obsolete, or otherwise not applicable to the current environment will include harmonizing global standards to accept foreign clinical data in bringing medical devices to market, modernizing mammography standards, embracing electronic submissions for devices and veterinary drugs, and removing an outdated inspection provision for biologics and outdated drug sterilization requirements to remove barriers to the use of certain sterilization techniques.

Regulatory changes also are being proposed for tobacco and food safety, Gottlieb says.

“Over the next year,” he concludes, “we will also tackle many additional priority areas through guidance documents and other policy efforts. These areas include efforts to reduce the cost of drugs by encouraging competition, spur innovation across medical products, give consumers access to clear and consistent nutrition information, create greater regulatory efficiencies in bringing products to market, and put a dent in the opioid addiction crisis facing our country.”