News & Analysis as of

Supply Chain Pharmaceutical Distribution

Goodwin

Navigating the New Normal: Biomanufacturing Goes Local

Goodwin on

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

WilmerHale

COVID-19: The Biden Administration's National Strategy and Plans for the Defense Production Act

WilmerHale on

On President Biden’s first two days in office, he issued a National Strategy for the COVID-19 Response and Pandemic Preparedness and 11 related Executive Orders, including an Executive Order on a Sustainable Public Health...more

Hogan Lovells

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

Hogan Lovells on

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

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

Morgan Lewis on

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

Morgan Lewis on

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

NHS medicine and device suppliers urged to carry out supply chain coronavirus risk assessment

Hogan Lovells on

At the end of last week, the World Health Organisation (WHO) upgraded the global risk assessment of the novel coronavirus to "very high." This comes shortly after the United Kingdom saw its first fatality as a result of...more

Patrick Malone & Associates P.C. | DC Injury...

FDA oversight looks shaky with drug recalls, rising vaping deaths and injuries

Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more

Mintz - Health Care Viewpoints

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public

Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more

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