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Biotechnology › Healthcare › Medical Devices

Hogan Lovells

Life Sciences in Poland: Post-registration changes in case of no-deal

Hogan Lovells on

On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event...more

Morgan Lewis

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

Morgan Lewis on

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Epstein Becker & Green

More of the Same: Recently Released FDA Social Media Guidance for the Life Sciences Industry

Epstein Becker & Green on

On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more

Polsinelli

FDA Targets Medical Device Companies

Polsinelli on

FDA Developing New Risk and Benefit Perception Scale - Since 2008, the U.S. Food and Drug Administration has increased its presence and tightened its control over medical device companies, and this trend is expected to...more

Burr & Forman

Best Practices For Laser-Assisted Cataract Surgery

Burr & Forman on

A femtosecond (FS) laser is exciting new technology, but it requires consideration of some important governance and compliance issues. Best practices require the surgeon and the facility (ASC or Hospital) to identify covered...more

Latham & Watkins LLP

10 Tips for Medical Technology Companies

Latham & Watkins LLP on

The Centers for Medicare & Medicaid Services (CMS) has initiated a new review process of existing national coverage determinations (NCDs). This new process is designed to retire old policies and may present increased risks to...more

King & Spalding

CMS Posts ICD Technology Assessment

King & Spalding on

CMS has posted a new technology assessment for implantable cardioverter-defibrillators (ICDs) addressing the evidence for use of ICDs for “primary prevention” of sudden cardiac death (SCD)—prevention of SCD in patients who...more

Manatt, Phelps & Phillips, LLP

Healthcare Law -- Aug 19, 2013

Manatt, Phelps & Phillips, LLP on

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more

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