FDA Law

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Pfizer, Inc. Department of Health and Human Services et al. July 25, 2022. Whether the Beneficiary Inducement Statute (BIS) is relevant to interpreting the AKS (essentially, no). Background.

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Manufacturing Medical Government IT 98

FDA Law

SEPTEMBER 7, 2022

Number of Manufacturing Sites and Registered Products. The report states that for fiscal year 2021, there were 4,451 CDER drug manufacturing sites, which is a 3% increase over fiscal year 2018, the only comparison year provided. For fiscal year 2021, CDER oversaw 12,428 ANDAs, 3,537 NDAs and 315 BLAs. Import Alerts and Recalls.

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FDA Law

DECEMBER 16, 2024

A similar support program, instead of or in combination with third party review, could be instrumental in assisting manufacturers of LDTs to validate tests and de-risk regulatory authorizations. We noted in last years post that in Fiscal Years 2018 2022 , fewer than 100 510(k)s went through the Third Party Review Program annually.

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Consulting Manufacturing Utilities Provider 52

FDA Law

JULY 18, 2023

Geography of Manufacturing Sites OPQ reports that as of October 2022, CDER’s manufacturing site catalog listed 4,814 facilities, a 12% increase over 2018. That leaves 60% that manufacture at least one application product. and South Korea. That number is notable because those sites comprised only 30% of inspections.

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Supply Chain Manufacturing IT Provider 52

FDA Law

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.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §

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FDA Law

JUNE 15, 2022

Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. 52494 (Nov. citing §1395 l (t)(14)(A)(iii)(II)).

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Hospital Government Provider IT 52

FDA Law

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The main body of the draft guidance provides high-level recommendations, and four appendices provide detailed recommendations for test design. In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,

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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?

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FDA Law

MARCH 6, 2022

FDA initially announced this plan in 2018, and it has previously appeared in FDA’s regulatory agenda. It is very common for a medical device manufacturing facility both to be certified as compliant with ISO 13485 and to have quality system procedures designed to comply with the FDA’s QSR.

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FDA Law

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ). Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

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Medical Electronics Manufacturing Utilities 64

FDA Law

SEPTEMBER 24, 2023

The nearly $7 billion window covering industry was well aware of the dangers of dangling cords and put industry standards in place in 2018 and updated them in 2022. Within two days of the final rule, the Window Covering Manufacturers Association filed suit at the D.C. It is also a hot-button issue for the U.S. However, as the D.C.

Appointment 59

Appointment Manufacturing IT 59

FDA Law

MAY 2, 2022

They are the most stringently regulated substances of abuse and it is unlawful to manufacture and distribute them. Attorney General Jeff Sessions rescinded prior DOJ guidance on marijuana enforcement, including the Cole Memo, in January 2018. Merrick Garland, Testimony Before the Senate Subcommittee on Appropriations, Apr. 21 U.S.C. §

Manufacturing 52

Manufacturing Medical IT Community 52

FDA Law

OCTOBER 25, 2021

It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. The new rule will be codified in 21 C.F.R. Part 860.

Manufacturing 52

Manufacturing Government Specialization IT 52

FDA Law

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ).

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

OCTOBER 20, 2021

As we have previously discussed , under the PMTA pathway, manufacturers must demonstrate that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. The original deadline for submission of PMTAs for products subject to the deeming rule such as ENDS products was August 8, 2018.

Electronics 52

Electronics Provider Manufacturing IT 52

FDA Law

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”.

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law

SEPTEMBER 20, 2021

When travel restrictions and public health precautions halt facilities inspections, many sponsors are left wondering how FDA will complete pre-approval inspections and meet their products’ respective PDUFA dates. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. In that letter, FDA stated that it would “permit manufacturers.

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Medical Manufacturing Individual Provider 59

The Clinical Problem Solvers

NOVEMBER 6, 2023

The developing attitudes about food scarcity and deficit models, and mass media’s manufacturing consent, has to be challenged, especially because there is a deep and rich history of Black people as farmers, gardeners, and ranchers that belies what Chimamanda Ngozi Adichie calls the danger of a single story. is rooted in anti-Blackness.

Community 52

Community Manufacturing Patients Medical 52

FDA Law

JUNE 24, 2021

Two years later, in 2018, FDA issued a Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices (see our blog post here ). The 2018 report listed several planned actions by the Agency, one of which was to clarify the difference between servicing and remanufacturing.

Manufacturing 52

Manufacturing Medical Provider IT 52

FDA Law

SEPTEMBER 5, 2023

Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations with DEA. FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018. Schedule III placement would loosen registration requirements for researchers. 10,499, 10,504-06 (Mar.

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GeriPal

MARCH 2, 2023

JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. Tasce: I do.

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Patient-Centered IT Healthcare Medical 96

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. 2018 Systematic Review of Systematic Reviews on ACP. All decisions are made in advance, the question that we are debating is how far in advance and what to call it. Completion of advance directives and billing codes for advance care planning as quality metrics. Among other topics.

Illness 72

Illness IT Healthcare Patient-Centered 72

FDA Law

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare. Emphasis added.)

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Medical Diagnosis Healthcare Clinic 53

FDA Law

FEBRUARY 4, 2025

The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs. This time, however, the program, which has helped incentivize the development of dozens of pediatric rare disease therapies since 2012, was not renewed.

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IT Vaccination Manufacturing Medical 52

FDA Law

APRIL 7, 2025

Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. The detail with which CVM reviewed these promotions is reminiscent of OPDP/DDMAC letters of yore.

Vaccination 64

Vaccination IT Manufacturing Screening 64

FDA Law

JUNE 10, 2025

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 90 Fed. We think that the agency will revise and update the list more frequently as clandestine manufacturing trends require. 21 U.S.C. § 21 U.S.C. § 842(a)(11). 21 U.S.C. § 842(a)(11).

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Specialization Manufacturing Electronics PCP 69

FDA Law

MAY 14, 2021

In November 2018, amidst an aggressive campaign against flavored e-cigarettes, the Trump administration announced plans to ban menthol cigarettes. In the same announcement, FDA also shared its intent to propose a product standard that would ban flavored cigars. Federal actions on menthol cigarettes. 21 U.S.C. § 387g(a)(1)(A). smoking.”.

IT 52

IT Manufacturing Specialization Community 52

FDA Law

MAY 14, 2021

In November 2018, amidst an aggressive campaign against flavored e-cigarettes, the Trump administration announced plans to ban menthol cigarettes. In the same announcement, FDA also shared its intent to propose a product standard that would ban flavored cigars. Federal actions on menthol cigarettes. 21 U.S.C. § 387g(a)(1)(A). smoking.”.

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IT Manufacturing Specialization Community 40

FDA Law

AUGUST 10, 2021

That proposal was withdrawn by the Trump HHS, but the notion of international reference pricing was subsequently incorporated in an October 2018 HHS Advance Notice of Proposed Rulemaking (ANPR) (see our post here ). Use of international reference pricing as a target for Medicare to negotiate prices with drug manufacturers appears in H.R.

Finance 52

Finance Insurance Manufacturing IT 52

FDA Law

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

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Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law

FEBRUARY 5, 2025

This proposed rule follows FDAs March 2018 advance notice of proposed rulemaking (ANPRM) regarding a potential maximum nicotine level for cigarettes. manufacturers would not need to formulate multiple products and prepare and submit premarket review applications at each phase of a gradual reduction approach). Philip Morris USA, Inc.

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Manufacturing Engineering Electronics IT 66

Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. Since 2018, this series has helped many patients and readers get their medical bills reduced, and it has been cited in statehouses, at the U.S. Winard said the hospital declined the offer.

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Insurance Screening Hospital Patient-Centered 52

FDA Law

MAY 26, 2025

2018), the district court ruled that Congress had exceed its constitutional bounds and had no authority to pass this law under the Necessary and Proper Clause or the Commerce Clause. 18-1156, 2018 U.S. Late last month the Attorney General issued a memo addressing both directives. First, it direct[s] all U.S. MedImmune, Inc.

Manufacturing 59

Manufacturing Provider Medical IT 59

FDA Law

SEPTEMBER 13, 2021

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Court of Appeals (again, see our post ). The pieces of major drug pricing and payment reform are falling together.

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Manufacturing Supply Chain Patient-Centered Utilities 98