SQA

JULY 8, 2022

SQA Regulatory Surveillance Summary 2022 – May. Health Canada, Non-Compliant Drug Inspections, 1Q 2022. inspected on 25 January 2022: findings relate to premises, manufacturing control, quality control, sanitation, stability, raw material testing, equipment, and records ( West Penetone Inc. Health Canada. Observations ).

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Hall Render

JULY 14, 2023

On June 7, 2023, the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first Untitled Letter of the year regarding violative promotional materials for a prescription drug indicated for the treatment of endogenous hypercortisolemia (high cortisol) in adults with Cushing’s syndrome.

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Healthcare Law Blog

MAY 31, 2022

However, traditional healthcare players, subject to the Health Insurance Portability and Accountability Act (“HIPAA”), may also find themselves innovating in this space (and grappling with how to stand up a HIPAA compliance program in the metaverse). 4] CDRH Proposed Guidances for Fiscal Year 2022 (FY2022) | FDA. [5] 1, 2021).

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SQA

FEBRUARY 15, 2023

Relevant matters are hereby announced as follows: As of 01 December 2022, the Electronic Certificates of Documentation for Export of APIs to the EU and Certificate of a Pharmaceutical Product will be put into use. Efforts should be made to promote and guide the use of electronic certificates.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

YouCompli

MARCH 29, 2023

CMS Updates to beneficiary PHE waivers that matter to healthcare compliance Sharon Parsley, JD, MBA, CHC, CHRC, contributes regularly to the YouCompli blog. HHS also advises that daily COVID-19 cases are down 92%, and that COVID-19 related deaths are down more than 80% since the peak of the January 2022 Omicron variant surge.

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Public Health COVID-19 COVID-19 Vaccine Medicare 52

SQA

MAY 17, 2022

SQA Regulatory Surveillance Summary 2022 – Spring. Brazil’s ANVISA Issues Registration Rules for Software, 01 April 2022. ANVISA has published new regulations focused on software as a medical device (SaMD), set to take effect on 01 July 2022. Agência Nacional de Vigilância Sanitária (ANVISA).

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Innovaare Compliance

MARCH 1, 2022

in 2022, which is partly offset by a cost-of-living increase of 5.9% The premium increase in 2022 was widely known to be attributable to the potential use of the Alzheimer drug, Aduhelm™ (aducanumab) by Medicare beneficiaries. [2] The monthly premium for Medicare Part B rose 14.5%, from $148.50 in 2021 to $170.00

Medicare 52

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SQA

DECEMBER 16, 2022

SQA Regulatory Surveillance Summary for September and October 2022. ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022. ANVISA published answers to questions received during an online seminar on clinical research of medicinal cannabis held in May 2022. 30 of 2022.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

SEPTEMBER 2, 2022

SQA Regulatory Surveillance Summary 2022 – June. Brazil’s ANVISA Repeals Medical Device Regulations Related to The Coronavirus Pandemic, 20 May 2022. ANVISA Extends Brazilian Good Manufacturing Practice Requirements to More Medical Device Manufacturers, 27 May 2022 . By Laurel Hacche & Debra Cortner SQA Associates.

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Hall Render

MARCH 29, 2023

It is hard to believe that spring is finally here and the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) has yet to take any enforcement action in 2023. Untitled Letters allow a company to correct the violations without any further FDA action. Practical Takeaways Letters.

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FDA COVID-19 Compliance 40

Healthcare Law Blog

JANUARY 12, 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Comments on the draft guidance are due on March 23, 2022. Guidance Overview.

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COVID-19 FDA Compliance Public Health 52

SQA

AUGUST 8, 2023

In August 2022, ANVISA published Resolution RDC 741/2022 , which sets the framework to consider other medical device market regulators’ authorizations. The affected lots of Emerade were distributed in Canada between April 2022 and May 2023. Recalls All Lots of Emerade Epinephrine Auto-Injectors (0.3 mt and 0.5 mg and 0.5

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

MAY 24, 2023

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility for the Quality and Safety of Medical Devices , which will come into force on 01 March 2023.

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SQA

OCTOBER 18, 2023

National Medical Products Administration (NMPA) China GLP Certification Regulation Takes Effect, 01 July 2023 After consulting on the draft in 2022, the NMPA issued the Administrative Measures for Drug Good Laboratory Practice (GLP) Certification earlier this year. As a result, the patient received 2.5

FDA 40

FDA Compliance Licensing World Health 40

SQA

DECEMBER 10, 2021

Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers, 02 August 2021. UDI compliance lead times for manufacturers will depend on the risk classification of their devices: Two years for Class IV (highest risk) devices. By Laurel Hacche & Debra Cortner SQA Associates. European Commission (EC).

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SQA

APRIL 12, 2023

SQA Regulatory Surveillance Summary for February 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Releases the Results of the 2022 Strategy, 31 January 2023 The ANVISA Strategy Performance and Results Evaluation Report is now available for consultation, for the year 2022.

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FDA Compliance Pharmaceutical Industry 40

SQA

OCTOBER 18, 2022

SQA Regulatory Surveillance Summary for July and August 2022. Counterfeit COVID-19 Antigen Rapid Test Kits Found in Ontario, 05 August 2022. The entire shipment, which contained 435 boxes of the 25-pack, was sent to Health Canada for compliance follow-up. Addendum to S1B Reaches Step 4 of the ICH Process, 15 August 2022.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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Healthcare Law Blog

OCTOBER 25, 2023

iii] The Act also authorizes the CT DCP to impose penalties for instances of non-compliance or violations of the Act. Other Jurisdictions of Note In addition to Connecticut, each of the jurisdictions below have a similar requirement for individuals marketing or promoting pharmaceuticals to healthcare professionals (“HCP”).

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Licensing Compliance FDA Public Health 52

Healthcare Law Blog

AUGUST 25, 2022

The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 2022. Drugs eligible for negotiation must be FDA-approved for at least 7 years and marketed in conformance with the Federal Food, Drug, and Cosmetic Act. Program Compliance. Negotiation-Eligible Drugs. Penalties under the Program are severe.

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Healthcare Law Blog

NOVEMBER 13, 2023

This proposal would shift the burden from CMS to the MA organization to demonstrate compliance with this standard. Please refer to our January 5, 2023 , November 4, 2022 and May 16, 2022 blog posts for more information.

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Medicare Medicare Medicaid Medicaid 59

SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies.

FDA 52

FDA Compliance COVID-19 Public Health 52

Drug & Device Law

DECEMBER 5, 2022

2022 WL 3147194 (C.D. 2022), review denied (Cal. July 13, 2022). at 462-63; FDA §510(k) clearance of the defendants’ instructions for use did not “actually bar” or “clearly permit” the IFU statements so as to create a safe harbor that precluded the Attorney General’s claims, id. Ethicon, Inc. 3d 424 (Cal.

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Doctors FDA Compliance 64

Drug & Device Law

DECEMBER 29, 2023

This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

JUNE 27, 2022

This post is from the non-Dechert side of the blog. June 6, 2022), in which the court denied the plaintiff’s motion for new trial and affirmed multiple helpful rulings on the admissibility and inadmissibility of FDA-related evidence. We have blogged about Africano three times before. Africano , 2022 U.S.

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FDA Governance Compliance 52

Drug & Device Law

JUNE 15, 2022

It appears intended to codify FDA regulatory authority over in vitro chemical tests, and is not the kind of thing we would ordinarily concern ourselves with on this Blog. It’s not like such tests have been a product liability hotbed. In fact, when searched for that term, we received zero results. c) Clarification.

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FDA Governance Licensing Compliance 52

Drug & Device Law

NOVEMBER 3, 2022

This post is from the non-Reed Smith side of the blog. Pizzitola I , 2022 U.S. The court said: [I]n the field of prescription drugs and medical devices, FDA approval is the key to making such a device feasible and available for physicians to use outside of an experimental setting. Pizzitola II , 2022 U.S. 7, 2022).

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Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As both the blog and many of us defense practitioners can attest, the statute before repeal, Mich. . 2022 WL 5265300 (D.N.J.

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FDA Compliance Fraud Hospitals 52

Drug & Device Law

JUNE 9, 2022

2022 WL 1261318 (3d Cir. 2022 WL 1261318 (3d Cir. In our initial post, we focused on the exception to the presumption, which allows liability to be imposed if a plaintiff alleges and ultimately proves that the defendant manufacturer committed fraud on the FDA. 2022 WL 1261318, at *2. Boston Scientific Corp.

Compliance 59

Compliance FDA Fraud 59

Drug & Device Law

JUNE 28, 2022

2022 WL 2276808 (U.S. June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications.

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Drug & Device Law

JUNE 5, 2023

April 21, 2023), became the latest decision to follow what used to be (before the Pelvic Mesh litigation used the law in this area as a settlement tool) the overwhelming majority rule, that FDA decisions to allow products to be marketed – including §510(k) clearance – were routinely admissible. The Kelley court agreed with the defendant.

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