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Recent Biden Administration Actions on Access to Medication Abortion

In the first week of 2023, the Biden administration announced two actions centered on expanding access to medication abortion. The first involves a policy change by the FDA regarding the ability of retail pharmacies to...more

The Health Care Priorities of the Biden Harris Administration and Post Election Outlook for the 117th Congress

In a historic presidential election that began during the COVID-19 pandemic and ended with record voter turnout and mail-in ballots, former Vice President Joseph Biden of Delaware was declared the 46th president of the United...more

President Signs Executive Order to Ensure Essential Medical Products Are Made in the USA

President Donald Trump signed an Executive Order (EO) on Thursday, August 6, 2020 directing federal agencies to “Buy American” when purchasing “essential” drugs, medical supplies and equipment rather than purchase these...more

FDA Issues New Guidance to Developers of COVID-19 Vaccines

On June 30, 2020, the U.S. Food and Drug Administration (FDA) released new guidance to provide recommendations for sponsors to facilitate development of SARS-CoV-2 vaccines to prevent COVID-19. The guidance highlights key...more

FDA Issues New Guidance to Developers of COVID-19 Drugs and Biological

On May 11, the U.S. Food and Drug Administration (FDA) released two guidance documents to provide recommendations for sponsors “to accelerate development” of drugs and biologics designed to prevent or treat COVID-19. ...more

FDA Issues Emergency Use Authorizations for Additional Medical Devices in Response to COVID-19

On Friday, April 10, 2020, the Food and Drug Administration (FDA) announced that it has issued two additional Emergency Use Authorizations (EUA) in response to the coronavirus pandemic: one for a device that is used to...more

FDA Issues Guidance on Supply Interruptions and Discontinuance Notification Requirements for Emergency and Life Supporting Drugs

On April 1, 2020, FDA issued a guidance document instructing companies on how to notify the agency of a permanent discontinuance or interruption of manufacturing of certain products pursuant to Section 506C of the FDCA (21...more

FDA Develops Program to Expedite COVID-19 Drug Review

In response to the public health threat of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has formed a special emergency program to expedite development of COVID-19 therapies – the Coronavirus Treatment...more

FDA Will Facilitate Biological Product Development Against COVID-19

The U.S. Food and Drug Administration (FDA) announced in a March 27, 2020 letter to industry that the Center for Biologics Evaluation and Research (CBER) has implemented new measures to prioritize biological product...more

What Biopharmaceutical and Medical Device Manufacturers Need to Know About the CARES Act

On March 27, 2020, Congress passed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the third and by far the largest stimulus package passed by Congress to respond to the COVID-19 outbreak. As discussed...more

Client Alert: FDA Taking Overdue Steps to Accelerate COVID-19 Diagnostic Testing

In response to the COVID-19 pandemic, and in light of the persistent shortage of diagnostic tests for the SARS-CoV-2 virus, the U.S. Food and Drug Administration (FDA) provided recent but overdue guidance on the use of its...more

Food and Drug Administration Issues Historic Proposed Rule and Draft Guidance on Drug Importation

On December 18, 2019, in a reversal of historic and substantive reservations, the U.S. Food and Drug Administration (FDA or Agency) issued a notice of proposed rulemaking (Proposed Rule) that, if finalized, would allow for...more

CMS Final Rule Requires Prescription Drug Pricing Transparency in DTC Advertising

On May 8, 2019, the Centers for Medicare & Medicaid Services (“CMS”) finalized the regulation (“Final Rule” or “DTC Rule”) requiring direct-to-consumer (“DTC”) prescription drug television advertisements to include the...more

Modernization of the 510(k) Pathway to Market Medical Devices

Introduction - Congress enacted the Medical Device Amendments in 1976 establishing the regulatory framework for evaluating safety and effectiveness of medical devices. The U.S. Food and Drug Administration (“FDA” or...more

CMS Proposes Requiring Prescription Drug Price Disclosure in Direct-to-Consumer Advertising

On October 15, 2018, the Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule requiring disclosures by pharmaceutical manufacturers of the list price for certain drugs and biologicals directly or...more

FDA Releases Two Guidances for Innovative Drug Development

On September 28, 2018 the U.S. Food and Drug Administration (FDA or Agency) issued two draft guidance documents focusing on clinical trial designs to advance drug development and competition. Both documents aim to streamline...more

FDA Issues Draft Guidance on Medical Device Accessories

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.” The draft guidance...more

Life Sciences Alert FDA Issues Draft Guidance on General Wellness Products

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “General Wellness: Policy for Low Risk Devices.” The draft guidance carves out a category of products, deemed “general...more

FDA Unveils Anticipated Draft Guidance for the Regulation of Laboratory-Developed Tests

On July 31, 2014, the Food and Drug Administration (FDA) provided Congress notice of its intent to issue draft guidance providing a risk-based framework for the regulation of laboratory developed tests (LDTs) under the...more

FDA Publishes New Guidance on Letters from Manufacturers to Health Care Providers

The Food and Drug Administration (FDA) issued a new guidance document on Dear Health Care Provider (DHCP) letters, titled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” DHCP...more

FDA is Soliciting Comments on Improving the Quality of ANDA Submissions

The Food and Drug Administration (FDA) announced the establishment of a public docket for comments regarding Abbreviated New Drug Application (ANDA) submissions to the agency. FDA is specifically looking for input regarding...more

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