2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over forty novel drugs and biologics and...more
In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and...more
Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more
In Washington: As reported yesterday, the “Gang of 10” Republican lawmakers met with President Joe Biden to negotiate on Covid-19 relief after offering a $618 trillion counterproposal that was less than one-third the size of...more
In Washington: A group of 10 GOP senators unveiled an estimated $618 billion coronavirus relief proposal on Monday ahead of a meeting with President Biden to discuss relief legislation. The group will meet with Biden and Vice...more
In December 2020 when this blog series was planned, national attention had turned from developing a COVID-19 vaccine to distributing it. The expectation was that this blog would focus on the successes and logistical...more
As government contractors, you have been caught between the Scylla and Charybdis of the COVID-19 pandemic. On the one hand, you have been required to continue to perform your government contracts to ensure the safety and...more
In the waning days of autumn, it appeared that Texas was destined for a dark winter. As recently as December 14, 2020, the Texas Department of State Health Services (DSHS) reported over 1.3 million confirmed cases of...more
As COVID-19 vaccine approvals and eventual distribution kicks into high gear, there has been a corresponding – and not particularly surprising – increase in cyber threat activity targeting both vaccine producers and other...more
Doctors, nurses, hospitals and other health care providers, should know that the pandemic has not deterred federal or state authorities from prosecuting false claims, HIPAA and other types of enforcement actions in...more
Earlier this month, the National Academies Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released its Final Framework to guide US distribution and administration of a COVID-19 vaccine, once available....more
In Washington: The House is set to vote on the two high-profile policy issues before leaving town for the two-week July 4 recess, however, neither of the measures is likely to be taken up in the GOP-controlled Senate,...more
On June 8, 2020, the Food and Drug Administration (FDA or Agency) issued temporary guidance to address concerns related to distribution of drug samples during the COVID-19 public health emergency....more
On 29 May 2020, the AFMPS issued a new decision which further extends the measures initially provided in the Decision 1 April 2020 concerning supply of specific medicinal products by another month. These measures were...more
With COVID-19 cases on the rise in the United States, some hospitals have faced shortages of FDA-approved drug products used to treat the disease. ...more
The Belgian Federal Agency for Medicines and Health Products (AFMPS) has announced that licensed hospitals are authorized to deliver medicinal products directly to outpatients during the COVID-19 pandemic....more
On 14 April 2020, the Belgian Federal Agency for Medicines and Health Products (AFMPS), published a news flash warning physicians of the risk of hemolysis associated with the use of hydroxychloroquine in patients with...more
The COVID-19 pandemic has impacted every industry, causing global economic changes and, consequently, extensive legislative amendments. There are no doubts that the pharmaceutical industry is the most affected. Since the...more
The catchphrase of the day is “social distancing” and it is the primary means of flattening the COVID-19 pandemic (the pandemic) curve by keeping contagious and healthy people apart. However, there is another kind of...more
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 needs, and $34.9...more
Massachusetts Department of Public Health Commissioner Monica Bharel issued three new orders concerning the COVID-19 emergency. ...more