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.

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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

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FDA Law Blog

JULY 29, 2024

The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters. Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry is intended to be a roadmap that first describes the change notification process outlined in 21 C.F.R.

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. This guidance document is still in effect today. use in education, construction, art, and jewelry).

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FDA Law Blog

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. Greater scrutiny of RUO products and those companies that manufacture them could be one of those doors.

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FDA Law Blog

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.

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FDA Law Blog

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). N/A June 30 The manufacturer must accept the price or counteroffer—with a rationale. CMS may respond to the counteroffer.

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FDA Law Blog

JANUARY 18, 2023

They are: Terms and conditions of the manufacturer agreement, including each party’s responsibilities. Approach for considering (1) the manufacturer-reported data elements and (2) evidence about alternative treatments. Process for the offer and counteroffer exchange between the Secretary and manufacturers.

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FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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FDA Law Blog

MARCH 1, 2023

The purpose of these two pilot programs was initially to inform development of a FDA rating system to characterize the QMM of a facility. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs). FDA staff served as pilot program observers, but also met with the contractors to provide feedback.

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FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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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. The speaker program should occur in a venue that is conducive to the informational communication.

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FDA Law Blog

MARCH 6, 2024

More information about the conference can be found here. For complete information on the conference, click here. Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. S for reduced registration fees.

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FDA Law Blog

FEBRUARY 27, 2023

In a case involving a challenge to a Freedom of Information Request (“FOIA”) submitted to DEA, the DOJ and DEA appear to now argue that DEA is a “component” of the DOJ and not an agency. The arguments in this case also highlight a longstanding frustration with obtaining FOIA information from the DEA. Aims Institute, PLLC, v.

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FDA Law Blog

OCTOBER 4, 2023

According to the court, the Constitution guarantees no right to conduct business with the government, so the consequences of that participation can be “conditioned by regulation” without being considered unconstitutional. Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing. Complaint at 10.

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FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. On Commerce, Manufacturing and Trade of the H. This ensures that every non-practitioner registrant is inspected periodically.

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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

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FDA Law Blog

APRIL 14, 2021

For more than a year we have been asking FDA to initiate virtual or remote inspections of drug manufacturing facilities. FDA has conducted only a handful of on-site inspections – and no virtual inspections – of drug manufacturing facilities since the COVID epidemic shut down foreign travel 13 months ago.

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FDA Law Blog

SEPTEMBER 6, 2022

Below we outline the Draft Guidance and highlight the new information in the 2022 Draft Guidance. Two of the new questions added in the Draft Guidance (Q22 and Q23) address the fact that monitoring and other administrative “startup” costs, and manufacturing costs are often higher in the first year compared to subsequent years.

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FDA Law Blog

JUNE 12, 2023

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. They have inspectors in the field everyday with eyes on the products, on the local manufactures, and on the distributors and retailers.

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FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. The case law on commission-based marketing agentsincluding the Sorensen decisionfollow in a similar vein. Marchetti , 96 F.4th

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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.

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FDA Law Blog

OCTOBER 10, 2022

Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information. Here again, FDA’s novel interpretation of statutory terms effectively narrows the scope of information that a software product can display, analyze, or print and still be considered Non-Device CDS.

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FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. On Commerce, Manufacturing and Trade of the H. This ensures that every non-practitioner registrant is inspected periodically.

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FDA Law Blog

JULY 6, 2021

If FDA violates this provision (or any similar provision) by forcing sponsors to perform studies after agreeing to their proposed studies based on scientific information long available to the Agency, it makes sense that the sponsor would want to challenge the decision both as soon as possible and prior to determining its next steps.

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FDA Law Blog

MARCH 20, 2022

Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA maintains a database for recalls of FDA-regulated products based on information gathered from press releases and other public notices. “It It is critical for firms in a product distribution chain to be “recall ready.””.

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FDA Law Blog

NOVEMBER 15, 2022

FDA allows for the following exemptions or waivers for user fees for medical devices (see here for further information). Any application from a State or Federal Government entity. BLA for product licensed for further manufacturing use only. Please see here for more information.). Exemptions or Waivers. Third-party review.

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FDA Law Blog

MARCH 6, 2025

We were struck by the level of detail expected by FDA for processes related to data management, especially for data collected and used early in development to train an initial AI model, which may occur before a manufacturer decides to move forward with device development under design controls.

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FDA Law Blog

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 This capacity limitation does not apply to OTC lateral flow antigen tests, which can be manufactured in the hundreds of millions per month at a much lower cost than RT?PCR Why is that? Background.

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FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

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FDA Law Blog

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

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FDA Law Blog

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. Javitt — As we approach our third year of COVID, one of the major questions from March 2020 eerily echoes today: where are all the COVID tests? Mistakes cannot be glossed over.

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FDA Law Blog

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. Javitt — As we approach our third year of COVID, one of the major questions from March 2020 eerily echoes today: where are all the COVID tests? Mistakes cannot be glossed over.

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FDA Law Blog

OCTOBER 17, 2023

Non-Addictive Medical Products to Treat Pain or Addiction The SUPPORT Act ( Public Law 115-271 ) mandated that FDA issue a guidance document to provide information on how the Agency can apply section 515B of the FD&C Act to non-addictive medical products intended to treat pain or addiction. Emphasis added.)

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FDA Law Blog

JUNE 12, 2022

FDA claim to proceed, even though the supporting allegation was that material information was withheld that might have led FDA to a different approval decision. In subsequent years, however, it appears that not all courts have adopted the holding of the ev3 decision. Specifically, last year, the Ninth Circuit allowed a fraud?on?the?FDA

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GeriPal

DECEMBER 7, 2023

So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there. Its major goal is to try to pull together information on aging and climate change for three groups. Karl: Sure.

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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.

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