FDA Law

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package.

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law

DECEMBER 16, 2024

We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule. As we have previously discussed, the Third Party 510(k) Review Program is not widely used.

Consulting 52

Consulting Manufacturing Utilities Provider 52

FDA Law

JUNE 24, 2024

The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development. The latest iteration, version 5.0, released in April 2024, marks the first update since 2020.

Manufacturing 52

Manufacturing Healthcare Education Utilities 52

FDA Law

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. The North Dakota law includes three reporting requirements for drug manufacturers.

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 52

FDA Law

JULY 13, 2022

If a drug that has been approved for 12 years—but less than 16 years—is selected for the Drug Price Negotiation Program, a biosimilar manufacturer can request a one-year moratorium on negotiations for that product so that the biosimilar manufacturer has time to secure licensure and begin marketing of the biosimilar version.

IT 52

IT Manufacturing Utilities Complication 52

FDA Law

MAY 27, 2024

With her return to the firm, she can now utilize her recent in-house experience to help HPM’s diverse client base solve complex problems. She was an outstanding lawyer before, and her in-house experience will provide even greater breadth and depth of expertise to medical device manufacturers,” notes Jeffrey Gibbs, HPM Director.

Manufacturing 59

Manufacturing Management Utilities Relationship 59

FDA Law

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?

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

Medical 59

Medical Provider IT Manufacturing 59

FDA Law

MARCH 27, 2023

Legacy FDA identification numbers refer to both National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers created using labeler codes previously assigned to device manufacturers by FDA. Devices that are manufactured and/or labeled on or after September 24, 2023, cannot use this alternative.” Emphasis added.)

Specialization 45

Specialization Supply Chain Manufacturing Medical 45

FDA Law

SEPTEMBER 20, 2021

Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage. 30, 2023; Public workshop on advancing innovative manufacturing technology, by end of FY 2023; Publish advancing innovative manufacturing technology strategy document, by Sept.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

OCTOBER 14, 2021

Given these onerous requirements, it is not a surprise that RAS device manufacturers have not sought clearance for RAS devices for oncology procedures. It would also be beyond the scope of what RAS device manufacturers are intending to offer, which is a better surgical tool, not a therapeutic for cancer. 21 U.S.C. §

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law

MAY 15, 2023

Manufacturers are responsible for determining that the common food is safe and has utility for its intended use prior to commercial distribution as animal food. However, while AAFCO is receiving feedback on this first proposed list of products, applications for additional common foods are not accepted.

Manufacturing 45

Manufacturing Utilities Provider IT 45

FDA Law

NOVEMBER 7, 2023

Well, what FTC apparently did was review hundreds of patents in the Orange Book and utilize FDA’s regulatory processes. But there’s no telling what the implicated manufacturers will do, because again, it is legally unclear whether the listing of the device patents is actually anticompetitive.

IT 59

IT Manufacturing Utilities Provider 59

FDA Law

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. However, as we noted above, the CMC topics covered in this draft guidance will be covered in Part 2 of this blog coverage.

Clinic 59

Clinic Provider IT Electronics 59

FDA Law

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. 14] Thus, while the Third-Party Review Program is not well‑utilized generally, it is not utilized at all by the in vitro diagnostic industry.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

MARCH 20, 2022

Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA has model recall communication templates available here that firms can utilize. Manufacturers hope for the best that their products are going to be used safely and effectively for patients and consumers.

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

IT 40

IT Education Utilities Patient-Centered 40

FDA Law

MAY 11, 2023

Koblitz — Well, we’re a little late to blogging about this, but the significance of the ongoing Teva v. GSK litigation to Hatch-Waxman aficionados makes this case still ripe for blogging. Six months after the Supreme Court asked the Solicitor General to submit a brief on behalf of the U.S.

Government 72

Government Manufacturing IT Utilities 72

FDA Law

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.

Lab Testing 98

Lab Testing Government IT Manufacturing 98

FDA Law

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.

Manufacturing 59

Manufacturing Utilities Provider IT 59

FDA Law

OCTOBER 16, 2024

By leaving intact Bristol-Myers Squibb , notwithstanding the argument that Loper Bright nullifies it, the Court preserved an important avenue for generic drug manufacturers. We note, however, that this is unlikely to be the last affront to the skinny-label, which clearly remains a target for RLD sponsors.

Manufacturing 98

Manufacturing Patients IT Hospital 98

FDA Law

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

Manufacturing 52

Manufacturing Screening Provider Clinic 52

FDA Law

SEPTEMBER 5, 2023

Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations with DEA. In addition, there was no consensus of experts opinion about the medical utility of cannabis treating specific recognized disorders.

Medical 111

Medical IT Manufacturing Utilities 111

FDA Law

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law

NOVEMBER 16, 2021

In addition, section 90004 of the Act requires manufactures of drugs sold in single-dose containers to pay refunds to Medicare for discarded Part B drugs. Manufacturers covered by this provision will have to pay refunds for discarded amounts beginning 18 months after the drug is first covered under Part B, but no earlier than January 1, 2023.

Manufacturing 40

Manufacturing Utilities Management Provider 40

FDA Law

AUGUST 21, 2023

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. FDA went so far as to issue a proposed rule (see our blog post here ), that ultimately went nowhere.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. Manufacturers receive no benefits in exchange for the inflation rebates.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

FDA Law

SEPTEMBER 14, 2021

The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law

JUNE 1, 2025

The bill would also mandate that drug manufacturers report payments to influencers to the federal Open Payments database, similar to current requirements for physicians. Maximizing patient clinical outcomes and quality of life may ultimately minimize healthcare resource utilization. Healthier populations are more productive.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98