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Life Sciences › Registration Requirement

Barnea Jaffa Lande & Co.

Drug registration reform in Israel: processes are being streamlined and timeframes shortened to increase supply and lower prices

Barnea Jaffa Lande & Co. on

We are living in an era of revolutionary medical innovation, particularly in the research and development of medicinal products. Diseases that were once considered incurable, are now treated with drugs, vaccines and...more

Quarles & Brady LLP

HRSA Notice Provides Clarity on 340B Child Site Registration Requirements

Quarles & Brady LLP on

After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...more

Quarles & Brady LLP

Nevada to Require Out-of-State Pharmacists that Dispense or Compound for Nevada Patients to Hold a Nevada Pharmacist’s License

Quarles & Brady LLP on

If you are a Nevada licensed non-resident pharmacy, you will soon be receiving notification from the Nevada Board of Pharmacy (“Board”) stating that any pharmacist who dispenses or compounds prescriptions for a controlled...more

Seyfarth Shaw LLP

Chinese Manufacturers of Personal Protective Equipment Gave False U.S. Agent Information to Food and Drug Administration

Seyfarth Shaw LLP on

U.S. health care providers should closely inspect PPE equipment bought from Chinese companies in light of recent revelations regarding the registration practices of approximately 1,300 Chinese entities....more

Morgan Lewis

Overview of Medical Device Regulation in China

Morgan Lewis on

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more

Hogan Lovells

Digital health solutions in Germany: Detailed requirements for eligibility to reimbursement being fleshed out in draft legislation

Hogan Lovells on

Introduction In November 2019, the parliament passed a new law which will provide reimbursement for digital healthcare provision for the around 70 million publicly insured patients in Germany (Digital Health Service...more

Hogan Lovells

Post-registration changes in case of no-deal Brexit

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

Hogan Lovells

A new year, a new disclosure: ICMJE requires registrations for clinical trials beginning in 2019 to include disclosure of data...

Hogan Lovells on

Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy published by the International Committee of Medical...more

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