FDA Law Blog

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. FDA extended PMTA compliance deadlines for years so it could figure out appropriate application instructions and so that manufacturers could figure out how to comply.

Manufacturing 115

Manufacturing IT Provider ER 115

FDA Law Blog

APRIL 2, 2025

FDA and the court agreed that the law does not require manufacturers to get preapproval before using a substance the manufacturer believes to be GRAS. The Government argues that the FDCA is silent on whether the manufacturer must notify FDA of GRAS conclusions. [A]s

Manufacturing 59

Manufacturing Government IT 59

FDA Law Blog

DECEMBER 11, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements. (See our post on this rule here.)

Manufacturing 59

Manufacturing Management Provider Government 59

FDA Law Blog

DECEMBER 9, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements. (See our post on this rule here.)

Manufacturing 59

Manufacturing Management Provider Government 59

FDA Law Blog

FEBRUARY 11, 2025

Gaulkin Drug manufacturers wont be receiving their first invoices for Medicare Part B and Part D inflation rebates until later this year, but rebates have been accruing since first quarter 2023 for Part B rebates and October 2022 for Part D rebates. The webinar will explore the legal and operational considerations for drug manufacturers.

Manufacturing 59

Manufacturing Management Government 59

FDA Law Blog

MARCH 6, 2024

His presentation will focus on “MoCRA is Here – Now What? Featuring speakers from the USPTO, FTC, FDA, distinguished members of the Judiciary, and in-house and outside counsel, HP&M Director Kurt Karst will be a presenter at the 20th Annual Paragraph IV Disputes Conference , April 25 – 26 in New York, NY.

Management 59

Management Manufacturing Specialization Government 59

FDA Law Blog

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law Blog

AUGUST 23, 2021

Kirschenbaum — On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals , which takes effect on January 1, 2022. By McKenzie E. Cato & Alan M. not friends, significant others, or family members of a speaker or invitee).

Specialization 52

Specialization Manufacturing Education Provider 52

FDA Law Blog

OCTOBER 4, 2023

However, Judge Newman distinguished Michigan Bell from the present case because the Michigan law, which compelled participation by the plaintiff telephone companies, denied them of their right to a “fair and reasonable rate of return.” See Motion at 11. Order at 22.

Provider 59

Provider Manufacturing IT Government 59

FDA Law Blog

OCTOBER 25, 2021

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted

Manufacturing 52

Manufacturing Specialization Government IT 52

FDA Law Blog

JUNE 7, 2023

The cases were both brought under the False Claims Act (FCA), the Civil War-era law that the government uses to claw back funds it pays out to parties that overbill federal programs. SuperValu is undoubtedly a victory for whistleblowers, and a shot over the bow for recipients of government reimbursements.

Government 40

Government Patient-Centered IT Manufacturing 40

FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week.

Consulting 52

Consulting Provider Manufacturing Specialization 52

FDA Law Blog

JULY 6, 2021

Koblitz — FDA has long taken the position that a Complete Response Letter (“CRL”)—a letter sent when FDA has determined that it “cannot approve” a New Drug Application (“NDA”) or an Abbreviated New Drug Application (“ANDA”) “in its present form”—is not a final agency action and thereby not subject to challenge in Court. 314.110(c).

Government 52

Government IT Provider Manufacturing 52

FDA Law Blog

APRIL 22, 2025

The stakes are high when a DEA-registered practitioner, pharmacy, distributor, manufacturer, or other registrant receives an Order to Show Cause (or OSC) from DEA. Both the government (represented by DEA counsel) and you will have an opportunity to present your case through witness testimony and record evidence.

Government 52

Government Provider Consulting Manufacturing 52

FDA Law Blog

JANUARY 11, 2024

Important to note here is that each interchangeable biosimilar was first approved as a biosimilar and each biosimilar manufacturer had been sued under the so-called “patent dance” procedure prior to seeking licensure of the biosimilar products as interchangeable.

Provider 59

Provider IT Manufacturing Complication 59

FDA Law Blog

MARCH 20, 2022

Almost all recalls are conducted on a voluntary basis by the manufacturer. Most FDA-regulated entities have an established SOP that governs the evaluation, decision, notification, and process for conducting a recall. It is critical for firms in a product distribution chain to be “recall ready.””.

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law Blog

AUGUST 17, 2022

We note, however, that some of the most important clarifications are not codified in the actual rule but are presented in the Preamble; thus, while FDA currently plans to interpret the rule as it states in the Preamble, it is not bound to do so. FYI, FDA does not use the term “regular hearing aids,” but we are for simplicity.)

Provider 40

Provider Manufacturing IT Government 40

FDA Law Blog

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.”

Government 72

Government Manufacturing IT Utilities 72

FDA Law Blog

AUGUST 3, 2022

3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. These products are subject to the same regulatory requirements as any unapproved medical device”).

Lab Testing 98

Lab Testing Government IT Manufacturing 98

FDA Law Blog

OCTOBER 17, 2023

If you are developing such products, now may be the time to explore the opportunities presented by the Breakthrough Devices Program. FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations.

Medical 53

Medical Diagnosis Healthcare Clinic 53

Tiny Physician

OCTOBER 17, 2021

The Kerala government has taken off all the restrictions imposed due to the case surge as caseload has come down, and is also planning to restart schools from the second half of November. The whole world is going through the sequelae of economic breakdown caused due to COVID 19 and governments are facing a shortage of funds.

Vaccination 52

Vaccination Government IT Clinic 52

FDA Law Blog

JUNE 1, 2025

Commissioner Makary has taken a more subdued stance, stating in a podcast with Megyn Kelly that FDA doesnt have any plans to ban direct-to-consumer advertising, but there are some things that we can do to make sure that the information being presented is a complete picture. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law Blog

JUNE 17, 2021

As we previously reported , the Final Rule and HHS’s certification thereof was swiftly challenged in court by the Pharmaceutical Research and Manufacturers of America (PhRMA), the Partnership for Safe Medicines (PSM), and the Council for Affordable Health Coverage (CAHC).

Government 52

Government Manufacturing IT 52

FDA Law Blog

FEBRUARY 12, 2023

manufacturers to authorize the use of their FDA-approved labeling to importers and either test the imported products or give information to importers to test the products so the importers can submit pre-import requests to the FDA. The final rule’s requirements for SIPs tracked the various statutory criteria of Section 804. Decision at 25.

Manufacturing 97

Manufacturing Government IT 97

FDA Law Blog

MAY 26, 2025

While ensuring that a pre-enforcement challenge is properly presented to a court is not a simple task, it can be done, and for those interested, there may be much to challenge. Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. MedImmune, Inc. Genentech, Inc., Gardner , 387 U.S.

Manufacturing 59

Manufacturing Provider Medical IT 59