FDA Law

SEPTEMBER 11, 2024

Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. For example, depending on the manufacturing process for a specific human drug, the use of some specific solvents, reagents, and catalysts may trigger the formation of these possible carcinogens. By John W.M.

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FDA Law

APRIL 8, 2024

Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. The report highlighted CDER’s Framework for Regulatory Advanced Manufacturing Evaluation Initiative and OPQ’s own Emerging Technology Program. By John W.M.

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Manufacturing IT 59

FDA Law

MARCH 7, 2024

Gibbs — Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical device submissions that require a user fee.

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Manufacturing Medical IT Provider 64

FDA Law

JANUARY 2, 2023

cGMPs and other manufacturing concerns relative to products liability. FDA Boot Camp is taking place virtually from March 22-23, 2023, visit [link] to learn more! This year’s conference co-chairs include Stacy Cline Amin (Partner, Morrison Forester) and Kurt R. Labeling in the drug and biologics approval process.

Manufacturing 59

Manufacturing Clinic Provider IT 59

FDA Law

JANUARY 18, 2023

They are: Terms and conditions of the manufacturer agreement, including each party’s responsibilities. 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.

IT 59

IT Manufacturing Provider Government 59

FDA Law

NOVEMBER 27, 2023

17, 2023, the Department of Justice (DOJ) announced the first-ever conviction of two corporate executives in a criminal prosecution for failure to report a consumer product defect under the CPSA. Then, earlier this year, in April 2023, Gree USA, Inc., See 15 U.S.C. § 2070. Now, fifteen years later, on Nov. and Gree USA Inc.

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Government Insurance Manufacturing Individual 104

FDA Law

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. Timeline Section 524B became effective on March 29, 2023. By Philip Won & Jeffrey K. Software in a Medical Device, or SiMD).

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Specialization Provider Medical Manufacturing 105

FDA Law

MARCH 27, 2023

So, what is special about September 24, 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. Most of the compliance dates have been passed. Emphasis added.) It is not far off!

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Specialization Supply Chain Manufacturing Medical 45

FDA Law

JULY 25, 2023

Nitrosamines are chemicals that can form during drug manufacturing, known by their scientific names as N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Meanwhile, manufacturers are on the hunt to find their quarry before their customers do it for them.

IT 52

IT Manufacturing Individual Medical 52

FDA Law

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission. See 21 CFR 807.81(a)(3)

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

DECEMBER 7, 2023

A regulatory consultant on the panel made a recommendation to FDA that it lean more heavily on Remote Interactive Evaluations (“REIs”) to help alleviate its backlog—of which HPM recently learned the Agency had only conducted 10 in the last 30 months for purposes of drug manufacturing compliance.

Consulting 52

Consulting Provider Manufacturing Specialization 52

FDA Law

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. CMS will develop a new online portal for manufacturers to review their reports, submit Suggestions of Error, and make rebate payments.

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Manufacturing Provider IT 59

FDA Law

SEPTEMBER 3, 2024

Some other noteworthy observations: More than half (8/15) of the recently posted decision summaries were from 2023. Given the high rate of innovation in the device industry, including the evolving field of AI, we expect more manufacturers to either submit De Novo classification requests or rely on those for their 510(k) devices.

Manufacturing 69

Manufacturing Medical Provider IT 69

FDA Law

MARCH 29, 2024

Many have noted that FDA has been slow to recover We’ve blogged before on FDA’s post-pandemic inspection work, writing about the resumption of both good manufacturing practice (GMP) and bioresearch monitoring (BIMO) inspections. By John W.M. Claud & Kalie E. Inspections went down—way down—during the pandemic. But gaps still remain.

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Clinic IT Manufacturing Government 59

FDA Law

SEPTEMBER 19, 2023

That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”. The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the.

Manufacturing 105

Manufacturing Provider IT Healthcare 105

FDA Law

JUNE 28, 2023

If a device manufacturer chooses to use an ASCA-accredited testing laboratory to conduct testing for premarket submissions to the FDA, the device manufacturer includes an ASCA declaration of conformity, an ASCA Summary Test Report and a cover letter that indicates that the submission contains ASCA testing as part of their premarket submission.

IT 52

IT Consulting Manufacturing Provider 52

FDA Law

JANUARY 29, 2023

Evans* — A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification.

Manufacturing 59

Manufacturing Consulting Government IT 59

FDA Law

NOVEMBER 20, 2023

It is the latest item on a long list of similar initiatives that have marked 2023. The changes at OPQ are the latest in FDA’s expanded 2023 quality efforts. Quality agreements between manufacturers and third-party suppliers are on FDA’s radar, and the Agency has shown a willingness to delay approvals in the face of quality concerns.

Manufacturing 59

Manufacturing Management IT Provider 59

FDA Law

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Manufacturers should, therefore, welcome any additional source of examples of device changes to aid in evaluating their own.

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Manufacturing Provider Consulting IT 64

FDA Law

FEBRUARY 21, 2024

It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. It also specifies that manufacturers document the Unique Device Identifier (UDI) for each medical device or batch of medical devices in accordance with Part 830, Unique Device Identification.

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Manufacturing Management Medical IT 59

FDA Law

JUNE 26, 2023

Chamber of Commerce (complaint here ), in New Jersey by Bristol Myers Squibb (complaint here ), and in Texas by Pharmaceutical Research and Manufacturers of America (PhRMA) and others (complaint here ).

Manufacturing 59

Manufacturing IT Government 59

FDA Law

AUGUST 14, 2023

Other interesting datapoints from her presentation: For the period from FY2000 to May of 2023, the percentages of drug manufacturing inspections with OAI classifications was lower in China (about 5% of inspections) than in the United States (8%). facility inspections are approaching traditional levels.

Manufacturing 52

Manufacturing Provider IT Medical 52

FDA Law

JUNE 22, 2023

FDA hailed its authorization of the Lucira OTC home test for influenza and COVID-19 as “underscor[ing] the Agency’s continued commitment to increase availability of accurate and reliable at-home diagnostic tests” ( April 2023 FDA Update to CDC ). By McKenzie E. Cato & Jeffrey N. Gibbs & Allyson B. lay users). seeking treatment).

Manufacturing 59

Manufacturing Clinic IT Medical 59

FDA Law

AUGUST 7, 2023

Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET. As a former participant, it was beneficial to me to engage with companies in person at their place of business and see the equipment used in manufacturing the medical devices that are reviewed by FDA.

Patient-Centered 40

Patient-Centered Insurance Manufacturing Provider 40

FDA Law

AUGUST 13, 2023

Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities. In the case of contract manufacturers, either the contract manufacturer or the person whose name appears on the label (i.e.,

Manufacturing 52

Manufacturing Electronics IT 52

FDA Law

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

Government 64

Government IT Manufacturing Illness 64

FDA Law

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

Manufacturing 59

Manufacturing Provider IT 59

FDA Law

AUGUST 27, 2023

As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. Drug manufacturers have had electronic systems in place since 2017. By Karla L.

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Supply Chain Electronics Manufacturing Provider 52

FDA Law

SEPTEMBER 15, 2024

2140, the Patent Eligibility Restoration Act of 2023 (“ PERA Act ”). IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Reading through the “Findings” section of S.

IT 76

IT Manufacturing Medical Provider 76

FDA Law

MAY 31, 2021

One of these amendments was a poorly thought-out rule that, if implemented, will render virtually unusable the current best price exclusion for manufacturer patient savings programs in the form of coupons, patient rebates/refunds, copay assistance, vouchers, and free drug programs. The effective date of this amendment is January 1, 2023.

Manufacturing 52

Manufacturing Insurance Patients IT 52

FDA Law

JUNE 17, 2024

Instead, the State of Pharmaceutical Quality Report provides more detailed statistics and data from FY2023 (October 1, 2022—September 30, 2023), and a clearer window into enforcement priorities. Medical gas manufacturers and 503B outsourcing facilities—both of which meet the definition of “manufacturer”—are excluded from the Quality Report.

Manufacturing 59

Manufacturing IT Provider Medical 59

FDA Law

JULY 17, 2022

Under the new law, Part B will continue to pay for discarded amounts from single-dose containers, but the manufacturer must pay a rebate (called a “refund”) to Medicare for discarded amounts above a specified threshold. Refunds will be payable for single-dose container drugs beginning on January 1, 2023.

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

FDA Law

APRIL 22, 2024

We blogged in February about the October 2023 letter from former DEA Administrators, Ms. Democratic senators also weighed in, supporting rescheduling to schedule III in December 2023. The senators note that DEA determined in prior rescheduling proceedings that 21 U.S.C. § On a final note, as a signatory to the Single Convention, U.S.

Manufacturing 59

Manufacturing Consulting IT Individual 59

FDA Law

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law

APRIL 3, 2023

By way of background, manufacturers are subject to an additional per-unit Medicaid rebate if they increase their prices greater than the rate of inflation. billion , respectively, in FY 2021), the impact on drug manufacturer rebates of CMS’s line extension definition, and the Court’s failure to overturn it, will be that much magnified.

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