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<br /> SPECIAL REPORT<br /> FDA 2018 YEAR<br /> IN REVIEW<br /> JANUARY 7, 2019<br /> TABLE OF CONTENTS<br /> 3 Introduction<br /> 4 Drugs<br /> 7 Digital Health<br /> 8 Drug Quality Security Act Implementation<br /> 11 Drug Supply Chain Security Act<br /> 12 Medical Devices<br /> 16 Laboratory-Developed Tests and Precision Medicine<br /> 16 Food<br /> 18 Tobacco<br /> 19 Cannabis<br /> 21 Advertising and Promotion<br /> 23 Clinical Investigations<br /> 24 Manufacturing and Good Manufacturing Practice<br /> 25 Enforcement<br /> 29 The Year Ahead<br /> SPECIAL REPORT<br /> LEARN MORE<br /> For more information, please contact<br /> your regular McDermott lawyer, or:<br /> VERNESSA T. POLLARD<br /> PARTNER<br /> vpollard@mwe.com<br /> Tel +1 202 756 8181<br /> VELEKA PEEPLES-DYER<br /> PARTNER<br /> vpeeplesdyer@mwe.com<br /> Tel +1 202 756 8639<br /> T. REED STEPHENS<br /> PARTNER<br /> trstephens@mwe.com<br /> Te<a title="FDA 2018 Year in Review page 1" href="http://viewer.zmags.com/publication/79ef3be3?page=1"> SPECIAL REPORT FDA 2018 YEAR IN REVIEW JANUARY </a> <a title="FDA 2018 Year in Review page 2" href="http://viewer.zmags.com/publication/79ef3be3?page=2"> TABLE OF CONTENTS 3 Introduction 4 Drug</a> <a title="FDA 2018 Year in Review page 3" href="http://viewer.zmags.com/publication/79ef3be3?page=3"> SPECIAL REPORT INTRODUCTION The US Food and</a> <a title="FDA 2018 Year in Review page 4" href="http://viewer.zmags.com/publication/79ef3be3?page=4"> DRUGS DEVELOPMENTS IN 2018 Citizen Petitions a</a> <a title="FDA 2018 Year in Review page 5" href="http://viewer.zmags.com/publication/79ef3be3?page=5"> may inhibit competition.” FTC noted its investiga</a> <a title="FDA 2018 Year in Review page 6" href="http://viewer.zmags.com/publication/79ef3be3?page=6"> consultation with FDA at an early stage of develo</a> <a title="FDA 2018 Year in Review page 7" href="http://viewer.zmags.com/publication/79ef3be3?page=7"> Proponents argue the proposed rule would prompt c</a> <a title="FDA 2018 Year in Review page 8" href="http://viewer.zmags.com/publication/79ef3be3?page=8"> certification level and the appropriate review pa</a> <a title="FDA 2018 Year in Review page 9" href="http://viewer.zmags.com/publication/79ef3be3?page=9"> • The compounding and repackaging of rad</a> <a title="FDA 2018 Year in Review page 10" href="http://viewer.zmags.com/publication/79ef3be3?page=10"> Under 503B, a compounded drug must not be essenti</a> <a title="FDA 2018 Year in Review page 11" href="http://viewer.zmags.com/publication/79ef3be3?page=11"> states. Under the MOU, a state must provide for a</a> <a title="FDA 2018 Year in Review page 12" href="http://viewer.zmags.com/publication/79ef3be3?page=12"> guidance provides the industry with the agency's </a> <a title="FDA 2018 Year in Review page 13" href="http://viewer.zmags.com/publication/79ef3be3?page=13"> digital health and to interpret the medical softw</a> <a title="FDA 2018 Year in Review page 14" href="http://viewer.zmags.com/publication/79ef3be3?page=14"> Special 510(k) Program On September 28, 2018, FDA</a> <a title="FDA 2018 Year in Review page 15" href="http://viewer.zmags.com/publication/79ef3be3?page=15"> Organization should apply for recognition and re-</a> <a title="FDA 2018 Year in Review page 16" href="http://viewer.zmags.com/publication/79ef3be3?page=16"> through a formal appraisal program to complement </a> <a title="FDA 2018 Year in Review page 17" href="http://viewer.zmags.com/publication/79ef3be3?page=17"> and vegetables that are raw agricultural commodit</a> <a title="FDA 2018 Year in Review page 18" href="http://viewer.zmags.com/publication/79ef3be3?page=18"> TOBACCO DEVELOPMENTS IN 2018 The deadline for i</a> <a title="FDA 2018 Year in Review page 19" href="http://viewer.zmags.com/publication/79ef3be3?page=19"> Finally, FDA is expected to issue a Notice of Pro</a> <a title="FDA 2018 Year in Review page 20" href="http://viewer.zmags.com/publication/79ef3be3?page=20"> Ramifications of the 2018 Farm Bill On December 2</a> <a title="FDA 2018 Year in Review page 21" href="http://viewer.zmags.com/publication/79ef3be3?page=21"> • Indicated that FDA will update its guidance o</a> <a title="FDA 2018 Year in Review page 22" href="http://viewer.zmags.com/publication/79ef3be3?page=22"> The guidance emphasizes that communicating inform</a> <a title="FDA 2018 Year in Review page 23" href="http://viewer.zmags.com/publication/79ef3be3?page=23"> and Research (CDER) Office of Compliance did not </a> <a title="FDA 2018 Year in Review page 24" href="http://viewer.zmags.com/publication/79ef3be3?page=24"> SPECIAL REPORT organization and presentation </a> <a title="FDA 2018 Year in Review page 25" href="http://viewer.zmags.com/publication/79ef3be3?page=25"> guidance is intended to outline the conditions un</a> <a title="FDA 2018 Year in Review page 26" href="http://viewer.zmags.com/publication/79ef3be3?page=26"> violations of cGMP, quality and other FDA require</a> <a title="FDA 2018 Year in Review page 27" href="http://viewer.zmags.com/publication/79ef3be3?page=27"> Campie et al., case number 17-936, now before the</a> <a title="FDA 2018 Year in Review page 28" href="http://viewer.zmags.com/publication/79ef3be3?page=28"> considerations, the government has concluded that</a> <a title="FDA 2018 Year in Review page 29" href="http://viewer.zmags.com/publication/79ef3be3?page=29"> SPECIAL REPORT THE YEAR AHEAD FDA's activi</a> <a title="FDA 2018 Year in Review page 30" href="http://viewer.zmags.com/publication/79ef3be3?page=30"> CONTRIBUTORS VERNESSA T. </a> <a title="FDA 2018 Year in Review page 31" href="http://viewer.zmags.com/publication/79ef3be3?page=31"> BOSTON 28 State Street Suite 3400 Boston, MA 021</a> <a title="FDA 2018 Year in Review page 32" href="http://viewer.zmags.com/publication/79ef3be3?page=32"> mwe.com |</a>