News & Analysis as of

Life Sciences Pharmaceutical Distribution

Quarles & Brady LLP

Georgia Board of Pharmacy Continues to Review Licensure Requirements for Pharmacists

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At the April 13, 2022 Georgia Board of Pharmacy meeting, the Board discussed changes to Chapter 480-36 which governs retail pharmacy remote drug order processing. The discussion was aimed at new verbiage that would require...more

Quarles & Brady LLP

California Board of Pharmacy Changes

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Over the last few months the California Board of Pharmacy has been busy considering several changes to its current rules and how it regulates various entities under its purview....more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Goodwin

Navigating the New Normal: Biomanufacturing Goes Local

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The pandemic has spared no industry. As fast-food chains have sought to drive business through chicken sandwich wars, Burger King’s release of its chicken sandwich was delayed in Michigan due to a shortage of pickle jars....more

Mintz - Health Care Viewpoints

Bioethics in a Pandemic: Laying the Foundation for the Draft Framework for Equitable Allocation of a COVID-19 Vaccine

With the release of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) on Tuesday and only a matter of days to provide comments, our next posts in the Bioethics in a Pandemic...more

Hogan Lovells

Belgian AFMPS abolishes quota previously imposed on paracetamol-based medicines

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The Belgian Federal Agency for Medicines and Health Products (AFMPS) has announced that it has abolished measures introducing quotas for the supply of paracetamol-based medicinal products. ...more

Hogan Lovells

FDA creates Coronavirus Treatment Acceleration Program to speed COVID-19 therapy development

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The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. ...more

Hogan Lovells

Japan considers utilization of “compassionate use” exception to fast-track COVID-19 treatments

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While several drugs are being studied in Japan to treat COVID-19, none have yet been approved. However, reports indicate remdesivir, a drug developed by as a treatment for Ebola virus disease, has been administered as a...more

Hogan Lovells

Spain responds to COVID-19 with new reporting obligations, supply chain controls

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The Spanish Ministry of Health placed on manufacturers and marketing authorization holders (MAHs) – or their local representatives – new reporting, supply, and manufacturing obligations with respect to 347 medicinal products...more

Morgan Lewis - As Prescribed

Uncharted Waters: Potential Regulatory Impacts of Coronavirus (COVID-19) on Pharma and Biotech Industries

With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact...more

Morgan Lewis

Potential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech Industries

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The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

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The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

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Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

Morgan Lewis

Overview of Medical Device Regulation in China

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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

Publication of rules on designation of expert panels under the Medical Devices Regulations

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In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision)...more

Hogan Lovells

Online sale of pharmaceuticals in Russia remains prohibited and lawmakers are yet to pass the bill allowing online sales

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Russian law currently prohibits the online sale of pharmaceuticals and requires that pharmaceuticals must be sold only in stationary pharmacies operated by a person holding a pharmaceutical licence....more

Hogan Lovells

The French Competition Authority issues its recommendations to lower prices of pharmaceutical products

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18 April 2019 Almost one and a half years after the launch of the sector inquiry, the French Competition Authority ("FCA") has released its conclusions on the functioning of competition in the pharmaceutical sector....more

Hogan Lovells

New Belgian legislation on the distribution of medical devices

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Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more

Mintz - Health Care Viewpoints

Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software,...more

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