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Food and Drug Administration (FDA) New Guidance Prescription Drugs

Goodwin

Year in Review: Top Regulatory Developments of 2023

Goodwin on

​​​​​​​As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023....more

Foley Hoag LLP

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

Foley Hoag LLP on

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

Foley Hoag LLP

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

Foley Hoag LLP on

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

Jones Day

FDA Announces Delayed Enforcement of Looming Supply Chain Requirements for Drugs Until 2024

Jones Day on

With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more

Nelson Mullins Riley & Scarborough LLP

Two new FDA Drug Supply Chain Security Act Guidances to help Pharmaceutical Supply Chain Partners Comply with the DSCSA’s move to...

The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more

Quarles & Brady LLP

More Guidance Released from FDA for Drug Supply Chain Security Act Compliance

Quarles & Brady LLP on

The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

Quarles & Brady LLP on

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Nelson Mullins Riley & Scarborough LLP

FDA Finalizes Informed Consent Guidance for Drug and Medical Device Clinical Investigations

On August 15, the U.S. Food and Drug Administration (FDA or the Agency) published the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final...more

Quarles & Brady LLP

FDA Announces Draft Guidance on Outsourcing Facility Sales

Quarles & Brady LLP on

The U.S. Food and Drug Administration (FDA) issued a draft guidance document, June 27, that describes FDA’s current thinking on the prohibition of wholesaling human drugs by a 503B outsourcing facility under the Food, Drugs,...more

Goodwin

FDA Guidance on Continuous Manufacturing of Drug Substances and Drug Products

Goodwin on

​​​​​​​In March 2023, the FDA issued a final guidance, titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products” that describes scientific and regulatory considerations for the development, implementation,...more

BakerHostetler

FDA Issues Guidance on Clinical Research with Cannabis

BakerHostetler on

On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical...more

Jenner & Block

Client Alert: New Year Brings New Guidance Related to Medication Abortion

Jenner & Block on

The federal government started 2023 by clarifying important legal issues surrounding the use of medications for abortions. These changes come after much uncertainty—and controversy—around the availability of medication...more

McDermott Will & Emery

After Almost 25 Years, FTC Issues New Health Products Compliance Guidance

McDermott Will & Emery on

The Federal Trade Commission (FTC) announced its Health Products Compliance Guidance on December 20, 2022. The 2022 guidance updates and replaces the FTC’s 1998 guidance, Dietary Supplements: An Advertising Guide for...more

Venable LLP

FTC Announces Health Products Compliance Guidance

Venable LLP on

On December 20th, 2022, the Federal Trade Commission published new guidance regarding claims about the benefits and safety of health-related products: Health Products Compliance Guidance. This guidance replaces the...more

Hogan Lovells

FDA offers new guidance on charging for investigational drugs

Hogan Lovells on

On Monday, the U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which responds to FAQs about FDA’s policies for charging...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

King & Spalding

A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making

King & Spalding on

In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more

Hogan Lovells

FDA finalizes guidance on Orphan Drug “sameness” of gene therapies

Hogan Lovells on

Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations,” which...more

Morgan Lewis - As Prescribed

Tracking Back to Track and Trace: Additional Guidance on Compliance with the DSCSA

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

Morgan Lewis - As Prescribed

FDA Provides Much-Needed Guidance on Master Protocols for COVID-19 Drugs

The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. ...more

Mintz - Trademark & Copyright Viewpoints

FDA Issues New Guidance on Drug Naming

Last week, the Food and Drug Administration (“FDA”) issued a pair of Guidance for Industry documents outlining best practices for developing proprietary names (i.e. brand names) for prescription and nonprescription human drug...more

King & Spalding

New FDA Guidance on Control of Nitrosamine Impurities

King & Spalding on

FDA Releases Guidance on the Agency’s Understanding of Nitrosamine Impurities - On September 1, 2020, the U.S. Food and Drug Administration (“FDA”) released a new guidance document, Guidance for Industry: Control of...more

Sheppard Mullin Richter & Hampton LLP

FDA Issue Guidance on Manufacturing Drugs, APIs during COVID-19

FDA issued new guidance on June 19, 2020, advising manufacturers of drugs, biologics, and active pharmaceutical ingredients (APIs) on manufacturing controls to prevent contamination of drugs with SARS-CoV-2, including...more

Verrill

FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and...

Verrill on

Prompted by a substantial increase in requests for individual patient access to investigational drugs and biologics to treat COVID-19, the U.S. Food & Drug Administration (“FDA”) issued guidance on June 2, 2020 that outlines...more

McDermott Will & Emery

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

McDermott Will & Emery on

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

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JD Supra Privacy Policy

Updated: Dec 28, 2021:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

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Links to Other Websites

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Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

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You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

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California Privacy Rights

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You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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Access/Correct/Update/Delete Personal Information

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Changes in Our Privacy Policy

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Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

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How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

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Controlling and Deleting Cookies

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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