Publications

Hogan Lovells Publications

Good Manufacturing Practice and the global supply chain

Supply chain oversight: what to expect from —and how to prepare for— an increasingly global supply chain and heightened FDA scrutiny

Hogan Lovells Publications

Influencer promo guide: Best practices for drug and device firms

All companies must be mindful of compliance with Federal Trade Commission (FTC) guidelines for influencers and marketers, which require, among other things, that ads and endorsements be...

Hogan Lovells Publications

China adds 30 drugs to its "urgently needed" list

Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications

Hogan Lovells Publications

With the statutory deadline approaching, FDA issues a proposed sunscreens rule

On 26 February, the U.S. Food and Drug Administration (FDA) published the proposed rule, "Sunscreen Drug Products for Over-the-Counter Human Use," which describes the conditions under which ...

Hogan Lovells Publications

Life sciences and health care horizons 2019

Hogan Lovells Publications

Brexit snapshot: Medicines

Do you have a centralised EU marketing authorisation holder, orphan designation holder, manufacturing activities including import, batch control or batch release sites, a Qualified Person...

Hogan Lovells Publications

DEA launches new ARCOS enhancement to help manufacturers and distributors "know your customer" and detect suspicious orders

The U.S. Drug Enforcement Administration (DEA) announced last week that it launched a new tool for its Automated Reports and Consolidated Orders System (ARCOS) Online Reporting System that...

Hogan Lovells Publications

Podcast series: False Claims Act 2018 and the road ahead

The pace of False Claims Act (FCA) litigation remained furious over the past year. Companies (and individuals) in all sectors of the economy continue to face the ever-present threat of FCA...

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