FDA Issues Guidance on Clinical Trials During COVID-19 Pandemic
As the coronavirus (COVID-19) pandemic continues to grow, the US Food and Drug Administration (FDA) on March 18 issued a guidance document titled FDA Guidance on Conduct of Clinical Trials of Medical...
View ArticleUncharted Waters: Potential Regulatory Impacts of Coronavirus (COVID-19) on...
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...
View ArticleFDA Issues New Policy for New Manufacturers of Hand Sanitizer
In light of the hand sanitizer shortage during the coronavirus (COVID-19) emergency, many companies have been trying to find alternative sources of product, especially employers in healthcare and...
View ArticleFDA Issues New Temporary Policy for the Manufacture of Alcohol for Hand...
In light of the hand sanitizer shortage during the coronavirus (COVID-19) pandemic, many manufacturers are seeking alternative sources of alcohol for incorporation into their hand sanitizer products....
View ArticleCARES Act Provisions Impact Drug, Device, and Food Manufacturers and Suppliers
The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical...
View ArticleFDA Issues Guidance on Postmarket Adverse Event Reporting During Pandemics
In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary...
View ArticleFDA COVID-19 Guidance Roundup for Drug and Biologics
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and...
View ArticleStaying Within the Legal Lane: Providing Products and Services for COVID-19
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory...
View ArticleFDA Adapts to the New Normal: Domestic Inspections Resuming Based on Tiered...
The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....<BR...
View ArticleThe PREP ACT: Critical Liability Immunity for Critical Products
As the coronavirus (COVID-19) pandemic resurges, PREP Act liability immunity continues to be critical for manufacturers and users of COVID-19 medical products....<BR />By: <a...
View ArticleLife Sciences International Review | August 2020
Welcome to the August 2020 issue of our Life Sciences International Review. This issue covers new developments within Asia, Europe, and the United States in intellectual property, regulatory, pricing,...
View ArticleHHS Limits FDA Oversight of LDTs Without Formal Rulemaking, Including During...
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory...
View ArticleFDA New Normal: Back to School with the A, B, CGMPs
The coronavirus (COVID-19) pandemic continues to impact the biopharmaceutical industry. In a recent guidance, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public...
View ArticleCOVID-19 Vaccines: Considerations for US Employers
As the world awaits a successful COVID-19 vaccine, employers are beginning to consider the implications a new vaccine will have on their workplaces. Although much remains speculative, employers can...
View ArticleHHS Expands PREP Act Liability Immunity
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act....By:
View ArticleWhat the Future May Hold for Pharma Regulation Under the Biden Administration
Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among...
View ArticleFDA Places Mexican-Made Hand Sanitizers on Import Alert Due to Toxin Risks
The Food and Drug Administration (FDA) issued a press release on January 26 announcing a countrywide import alert on all alcohol-based hand sanitizers manufactured in Mexico due to their potential...
View ArticleVaccine Development and Distribution: Legal Considerations for US Healthcare...
As the United States races to deliver safe and effective coronavirus (COVID-19) vaccines under the Biden administration, employers, healthcare providers, and many others are assessing what it means for...
View ArticleFDA Issues More Guidance on Gene and Cell Therapy Products
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic...
View ArticleSesame Becomes Newest Major Food Allergen
US President Joseph Biden signed into law the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) in April, establishing sesame as the ninth major food allergen under the Federal...
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