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In Search of Harmonization: FDA Finalizes Device CGMP Regulation Harmonization with ISO 13485:2016

On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more

FDA’s Major Statement: The Agency’s Recent Direct-to-Consumer CCN Final Rule, Q&A Guidance and Enforcement Trends

On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more

OMB Releases Artificial Intelligence Memorandum to Federal Agencies

Following the landmark October 30, 2023 executive order on artificial intelligence (AI), the White House Office of Management and Budget (OMB) issued a draft memorandum to federal agency heads for the use of AI within their...more

FDA Releases First New COVID-19 Vaccine BLA Guidance Since 2020

Executive Summary - On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more

President Biden Issues Executive Order on Use of Artificial Intelligence in Healthcare Settings

On October 30, 2023, President Biden issued an executive order (EO) to guide federal agencies on the development and use of artificial intelligence (AI). The administration views AI as holding numerous benefits but at the...more

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

Are You Not Interchanged? FDA’s Recent Biosimilar Labeling Guidance Chips Away at Interchangeable Product Advantages.

Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance. FDA justified its reversal on including the...more

Competing Rulings Issued on Access to Mifepristone, FDA Seeks Emergency Appellate Relief

Key Takeaways: Two competing federal court preliminary injunction orders were issued April 7, 2023, which have put the continued availability of mifepristone, the primary drug used for the medical termination of pregnancy, in...more

Mifepristone Update: Texas Judge Probes Extent to Which Court Can Affect the FDA’s Approval

Although the press was permitted to attend the hearing, news coverage has been limited and without significant detail of the back-and-forth between the judge and the parties. Nevertheless, the judge’s questions, as reported...more

Preparing for Impact: The Mifepristone Case in Texas Nears a Decision

The legal status of mifepristone and misoprostol, drugs legally prescribed by physicians since 2000 for the medical termination of early pregnancy, may soon be decided by a federal court in Texas in a lawsuit known as...more

FDA Issues Safety Communication About Genetic Non-Invasive Prenatal Screening Tests

Last week, the Food and Drug Administration (FDA) issued a safety communication warning the public about the potential risks of false results with genetic non-invasive prenatal screening tests (referred to as “NIPS” or...more

FDA Releases the Latest in a Series of Draft Guidance Documents on Real World Data

Earlier this week, the Food and Drug Administration released the latest in a series of draft guidance documents on the topic of real-world data (RWD) to support regulatory decision-making for drugs and biological products....more

FDA Updates Select Q&As on Biosimilar Regulation

The Food and Drug Administration (FDA) updated a final guidance and a companion draft guidance (the “first draft guidance”) providing answers to questions related to the agency’s regulation of biosimilar products and its...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

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

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