Dot Compliance

SEPTEMBER 30, 2022

It focuses on specific persons and processes involved in the production of goods and stops them from straying from quality standards like FDA 21 CFR Part 11, ISO and ICH Q10. Prior to ISO 9001:2015 , the standard for Quality Management Systems (QMS) was ISO 9001:2005. For cGMP compliance, the FDA audits authorized drug manufacturers.

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FDA Pharmaceutical Industry Compliance 52

HIT Consultant

AUGUST 18, 2021

Food and Drug Administration (FDA), along with greater flexibility around mandates on alternatives to traditional clinical information. These approaches have combined to help accelerate FDA review and study commencement timelines to as low as 30 days. As mentioned, they also began accepting submissions in pieces on a rolling basis.

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COVID-19 COVID-19 Vaccine Pharmaceutical Industry FDA 52

Dot Compliance

SEPTEMBER 11, 2022

Prior to ISO 9001:2015, the standard for Quality Management Systems (QMS) was ISO 9001:2005. The United States Food and Drug Administration (FDA) has the authority to enforce compliance with the Code of Federal Regulations , which has significant consequences if disregarded.

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Pharmaceutical Industry Compliance FDA Regulatory Compliance 52

Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

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FDA Compliance 52

Bill of Health

AUGUST 29, 2022

325, 338 (2005). [21] Barnette , 319 U.S. 624, 63 S.Ct. 1178.”); Kelsi Brown Corkan, Free Exercise in Foster Care: Defining the Scope of Religious Rights for Foster Care Children and Their Families , 72 U. 21] Colby, supra note 206, at 55. [22]

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SQA

AUGUST 8, 2023

The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005. Although this Toolkit provides PCPC’s current thinking on MoCRA, companies should be mindful that MoCRA represents meaningful new authorities that FDA has yet to interpret and apply. cosmetic regulatory framework.

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FDA Compliance COVID-19 World Health 40

Bill of Health

NOVEMBER 4, 2024

Food and Drug Administration (FDA) regulates tampons and menstrual cups as Class II medical devices. However, the FDA does not require tampon makers to test their products for PFAS or heavy metal contaminants. However, the FDA does not require tampon makers to test their products for PFAS or heavy metal contaminants.

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Kaiser Health News

FEBRUARY 9, 2023

The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. While they do plan to appeal the ruling should the FDA lose, the upheaval that could happen in the meantime can’t really be overstated.

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US Department of Health and Human Services Medicare Medicare FDA 52

Drug & Device Law

MARCH 7, 2024

We recall that FDA was so impressed with the first published studies supporting PrEP that it asked the manufacturer of the study drugs—a three-in-one pill—to apply for the novel indication. The manufacturer of tenofovir and the original PrEP drugs also manufactures remdesivir, which has been one of the main antivirals to treat COVID-19.

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Drug & Device Law

JANUARY 25, 2024

308 (2005), which comes up not infrequently in drug and device product liability cases. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. This is not the same as federal question removal, as defined in Grable & Sons Metal Prods., Darue Eng’g & Mfg. ,

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Medicare Medicare FDA Regulatory Compliance 52

Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. 2d 439 (2005): [A]t the time this [product] was sold, it complied with all safety standards. 3d 1245 (N.J. 2d at 1013-14. Beloit Corp. ,

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Drug & Device Law

JANUARY 8, 2024

The Acetaminophen MDL was a classic example, where the FDA had independently looked at the science no fewer than six times (in 2014, 2015, 2016, 2017, and 2022, and 2023) and each time concluded that the science did not justify any warning. 2005); United States v. 2d 147, 165 (E.D.N.Y. 2001), aff’d , 303 F.3d 3d 256, 270 (2d Cir.

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FDA 52

Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).

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COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

DECEMBER 4, 2023

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. American Home Products , 2005 WL 2277518, at *11 (S.D. 16, 2005); Huntman v. Plaintiffs Legal Committee , 531 U.S. 341 (2001). 2023 WL 7019287, at *7.

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Fraud FDA Hospitals Doctors 52

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 2005); Cuyler v. Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , North Central Behavioral Health System, Inc. , 2d 4, 7-8 (Ill. 2004); Sheetz v.

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FDA Governance Nurses Hospitals 59

Drug & Device Law

JULY 13, 2023

When we have given talks on preemption, whether to law firm personnel, attendees of professional conferences, or new FDA employees, we have tended to start with the Supremacy Clause and then break up the types of preemption and the issues related to them into different buckets. The most famous of these is probably Bates v.

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Drug & Device Law

JUNE 2, 2023

3d 411, 422-23 (2005). We’ve often said that we like preemption being a question of law because, on the whole, we expect that our FDA-related facts will more persuasive than the other side’s, so we want courts to decide these issues as soon as possible. Varghese v. Honeywell International, Inc. , Not anymore.

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Drug & Device Law

MARCH 16, 2023

We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway. Mensing , 564 U.S. 604 (2011), and Mutual Pharm. Bartlett , 570 U.S. 472 (2013). 2023 WL 2386776, *3. citing Gross v.

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Drug & Device Law

FEBRUARY 13, 2023

Those allegations, Pietrantoni held, sufficed to state an unpreempted (because the PAC program was apparently not FDA required) claim for negligent performance of a voluntarily assumed duty. 2005) (emphasis original). In a lot of ways Pietrantoni is a pretty good case for the defendants. A defendant’s “failure to inspect. . .

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Drug & Device Law

FEBRUARY 2, 2023

Wyeth , 2005 WL 544222, at *6 (N.D. March 4, 2005), rev’d on other grounds , 462 F.3d Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law.

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Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

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FDA Fraud Governance Medicare 72

Drug & Device Law

AUGUST 9, 2022

The first thing defendant asked the court to do was take judicial notice of the drug’s labels from the FDA website. Failure to warn is not preempted if the defendant could have changed the label without FDA approval via the Changes Being Effected (CBE) regulation. The court granted that request on two grounds.

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FDA Governance 52

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 2005 WL 3440440, at *5-6 (D.N.J. Bayer HealthCare Pharmaceuticals, Inc. , 3d 1223, 1233 (11th Cir. Smithkline Beecham Corp. ,

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Drug & Device Law

APRIL 25, 2022

Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. 2015) (“we will not consider evidence of a subsequent improvement to a drug label as evidence of prior failure to warn, even in cases such as this in which the FDA mandated the change in labeling”) (citing Rule 407).

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FDA Governance 52

Drug & Device Law

APRIL 21, 2022

Plaintiffs alleged that manufactured had failed to investigate and report the event to the FDA as purportedly required. For example, the court took judicial notice of an FDA recall notice. In support of that allegation, plaintiffs pointed to a particular adverse event that was noted in a recall notice. 2022 WL 1076173, at *5.

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Drug & Device Law

APRIL 19, 2022

Not too long ago we researched precedent that forbade persons claiming to be “FDA experts” from opining that products are “adulterated” or “misbranded.” 2005 WL 730688, at *4 (E.D. March 29, 2005) (same). But since we recently ran across an unusually favorable new case on this subject, we thought we’d address it again.

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Drug & Device Law

MARCH 28, 2022

In a recent post , we discussed a decision that, among other things, excluded an FDA expert’s “opinion” that the defendant’s medical device was “adulterated” and/or “misbranded.” Here, we’re focusing on expert opinions misusing these FDA terms of art. In Robinson v. Ethicon, Inc. 2022 WL 614919 (S.D. of Bexis’ book. In Sadler v.

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