FDA Law Blog: Biosimilars

APRIL 22, 2025

Both the government (represented by DEA counsel) and you will have an opportunity to present your case through witness testimony and record evidence. We also regularly blog on DEA administrative cases and procedures (see here ), and our HPM attorneys have authored articles (see here and here ) on the DEA hearing process.

Testimonials

FDA Law Blog: Biosimilars

FEBRUARY 6, 2024

We’ve blogged previously on the troubles FDA has faced ramping up its foreign inspections program after the pandemic. Mr. Claud was joined in his testimony by Mary Denigan-Macauley , a Director for Health Care at the Government Accountability Office (GAO) and Dinesh Thakur. Mr. Claud closed his testimony echoing that sentiment.

Testimonials

Translation

MAY 28, 2022

The post R&D Partnering Testimonials from Bayer, Oldcastle and Joyn Bio appeared first on Translation | Halo Blog.

Testimonials

FDA Law Blog: Biosimilars

DECEMBER 12, 2024

The purpose of the public hearing is to receive factual evidence and expert opinion testimony on whether marijuana should be rescheduled to schedule III. Parties will have ninety minutes to present the testimony of their witness. Prehearing Ruling (Dec. 4, 2024), at 1.

Testimonials

Perficient: Drug Development

OCTOBER 17, 2023

Encourage colleagues to write blogs on Cultural Connections removes unconscious Reinforces diversity and inclusion ​. This blog post is a celebration of Perficient’s culture and its promise to championing diversity and inclusion. Plan activities and events around culture that aids in creating a sense of belonging ​.

Testimonials

FDA Law Blog: Biosimilars

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. Inspections went down—way down—during the pandemic.

Clinical Research

Perficient: Drug Development

JANUARY 23, 2024

Resolution #4: Let your authenticity show I’ve talked about authenticity several times on the Perficient blog, and it is one of my favorite subjects. One way is to lean into consumer quotes and testimonials, whether patients or clinical profiles. Think about how some of the tactics could be applied to your organization or product.

Marketing

The Open Targets Blog

APRIL 25, 2023

My impression from their testimonies is that they must have felt a great sense of a common purpose and the importance of their work, despite the necessary secrecy and sometimes drudgery involved. A diverse group of people were recruited to Bletchley Park. ranging from university academics through engineers and clerical staff to the military.

DNA

Agency IQ

MARCH 1, 2024

Per a statement from a 2014 shutdown (which has been scrubbed from the FDA’s web pages, but was captured in this FDA Law Blog article ), the agency “will not be able to accept any regulatory submissions… that require a fee payment and that are submitted during the lapse period.” What happens in the longer term?

Government

FDA Law Blog: Biosimilars

JULY 21, 2024

In alleging that antibiotic use was a public health problem that FDA should regulate, the plaintiffs offered several testimonials from ostensibly affected people. Alliance for Nurses started as a Citizen’s Petition back in 2016, making its way to District Court when FDA took no action.

Nurses

The Pharma Data

MAY 14, 2021

For more information on Scott Sonnon, please visit his blog. All testimonials on this site are real. Required Legal Disclaimer: Due to recent laws from the FTC, it is required that all companies identify what a “typical” result is. However, the results described are meant as a showcase of what the best, most motivated.

Packaging

Perficient: Drug Development

SEPTEMBER 6, 2023

blog articles) or some blending thereof (e.g., The patient story is nearly unique among testimonial content, and it’s wholly unique to healthcare. Simple testimonials can share positive experiences a customer had with a product or service. Most content for healthcare organizations is conversion-focused (e.g., email campaigns).

Testimonials

FDA Law Blog: Biosimilars

APRIL 8, 2024

In 2022, the Government Accountability Office (GAO) reported that FDA needed to improve its foreign inspection program and that report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony.

Drugs

FDA Law Blog: Biosimilars

MARCH 14, 2023

Merrick Garland, Testimony Before the Senate Judiciary Committee, Mar. AG Garland concluded that he anticipates DOJ’s cannabis policy will be consistent with what he said during his confirmation in that “it will be very close” to the Cole Memorandum. 1, 2023 ( 02:38:46 ).

Testimonials

The Pharma Data

MAY 13, 2021

I have been in contact with Rick for only a few months now, but his Muscle Imbalances Revealed DVDs and blog have really helped me out immensely. Physical Therapist and Athletic Trainer. Former New England Revolution Therapist / Trainer. “I He has a way of bringing his knowledge across very efficient and effectively. And I think itâ??s

Production

The Pharma Data

MAY 14, 2021

testimonials that my happy customers have graciously sent me from. story or testimonial to tell me about the results you’ve achieved – and. Testimonials. | The information provided here is PROVEN to work for any man or woman at any age looking for an easy and effective way to cure Shingles. on its own. I’ve.

Treatment

Codon

JUNE 2, 2024

In a testimony in front of the U.S. In his spare time he enjoys blogging about biotechnology. While the use of inbred mice was initially constrained to research on the genetics of implanted tumors, the research applications of the lab mouse expanded greatly following a 1938 grant from the newly established National Cancer Institute.

Laboratories

Drug & Device Law

FEBRUARY 20, 2023

7, 2022), which addressed the same question in the context of the admissibility of expert testimony. Therefore, Davis excluded as “not relevant” expert testimony about non-FDA-approved alternatives. His testimony is thus irrelevant and inadmissible. Well, that’s what the Blog is here for – and that’s what prompted this post.

FDA

Drug & Device Law

DECEMBER 27, 2022

What follows is from the non-Dechert side of the Blog. Reliance on “animal data” – another notorious and frequent error common in unreliable expert testimony. 3d 1152 (S.D. Relying on the grossly excessive ranitidine exposure lab tests previously excluded for their bizarre results and shoddy methodologies.

Laboratories

Drug & Device Law

FEBRUARY 11, 2024

We’ve blogged several times already about the Alliance for Hippocratic Medicine v. 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. FDA litigation that is now before the Supreme Court. See , e.g. , Whole Woman’s Health Alliance v. Rokita , 2021 WL 650589, at *12-17 (Mag.

FDA

Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. They excluded bogus expert testimony under Fed. Bonta , 85 F.4th Monsanto Co. ,

Testimonials

Drug & Device Law

FEBRUARY 25, 2022

Courtesy of the Second Circuit, as we blogged here , Connecticut will be the second state high court to determine whether state law allows a “warning” claim based on another of the other side’s favorite preemption avoidance theories ? Notice how admissibility of expert testimony under Fed. case ( Conte ) in 2009. SC20607 (Conn.

Testimonials

Drug & Device Law

JANUARY 5, 2024

I am excited to join the Drug & Device Law Blogging Team. A more fulsome discussion of the Washington Supreme Court’s answer is on the Blog. Plaintiffs had no evidence to rebut the treater’s clear testimony. For readers noticing the new byline, let me introduce myself. The best group of legal wonks there is.

Testimonials

Drug & Device Law

JUNE 23, 2023

We’ve blogged before about the plaintiffs’ self-defeating “injury” definition in the Taxotere mass tort litigation. Plaintiff Adams’ “sworn testimony and plaintiff fact sheet” established that she blew the statute of limitations by some eight years. This wasn’t a close case. at *34-35.

Testimonials

Drug & Device Law

JANUARY 28, 2022

Thanks to the Connecticut Supreme Court, blog readers can stop staring with guilt and/or determination at that copy of Moby Dick on the bookshelf and instead print a sprawling copy of Fajardo v. Plaintiffs failed to produce such expert testimony, which was “fatal to [their] claim under the reasonable alternative design theory[.]” Id.

Testimonials

Drug & Device Law

MARCH 4, 2024

Plaintiffs will not be heard to argue that they “could have shored up their cases by other means had they known their expert testimony would be found inadmissible.” His inability to produce admissible expert testimony is due to his own actions, namely the failure of his proposed experts to test their alternatives. Weisgram v.

Testimonials

Drug & Device Law

JUNE 13, 2023

In the “ 50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping ,” the Drug & Device Law Blog (the Best Blog on the Planet) describes West Virginia as a “gatekeeper” state because of cases reflecting adoption of the Daubert analysis of W. 702 by the Supreme Court of Appeals of West Virginia.

Testimonials

Drug & Device Law

JUNE 20, 2023

Since 2018, we have blogged several times about the federal government’s crackdown on abusive False Claims Act (“FCA”) litigation via motions for dismissal, and how the abusive relators have tried to resist those efforts.

Government

Drug & Device Law

DECEMBER 20, 2023

We are even more likely to blog about a case if it follows up on an earlier decision about which we scribbled. We have blogged about this prosecution twice before. When we represented the United States of America, we were often in court, often on our own, and yet often dealing from positions of strength.

Trials

Drug & Device Law

DECEMBER 28, 2022

It is hard to beat Bexis’s lists of the best and worst DDL cases, the latter of which graced us last week , and the former of which will adorn this blog tomorrow, for inventorying what happened and what mattered in our area of the law in 2022. But it really is folly to plan the future without learning from the past.

Science

Drug & Device Law

OCTOBER 11, 2023

The Blog has compiled an “ E-Discovery for Defendants Cheat Sheet ” (yes, we know, it needs updating) of decisions favoring defendants seeking discovery of plaintiffs’ social media activity. We searched, and the word “medical,” and it doesn’t appear anywhere in LCJ’s thirty-plus page submission. We also have another concern. 3d 520 (M.D.N.C.

Testimonials

Drug & Device Law

DECEMBER 5, 2022

The Blog examined the excesses of such litigation here , here , and here , among other posts. 239, 253 (2012) (which the Blog discussed here ). The Superior Court here “credited testimony from doctors who never implanted mesh, or who did so outside the state of California.” Fox Television Stations, Inc. , Petition at 13.

Testimonials

Drug & Device Law

MARCH 23, 2022

But the Clowe court’s handling of the failure to warn claim meets with DDL blog approval. The plaintiff lawyers had managed to extract some testimony from the prescriber that he would have read with interest any additional information about the mesh product’s complication rates. This ploy often works at doctor depositions.

Doctors

Drug & Device Law

JUNE 6, 2023

So, we could not resist blogging about a Texas court reaching the exact opposite conclusion. So, at most plaintiff had her experts’ testimony that defendant did not do enough testing. Earlier this year we posted about an excellent magistrate decision in Baksic v. Ethicon Inc., 2023 WL 1192538 (Mag.

Testimonials

Drug & Device Law

NOVEMBER 27, 2023

Thus, when the other side inveigles one of ours to switch sides – usually with the promise of a lot more money for a lot more testimony – the result can be a lot of collateral litigation. We’ve blogged a couple of times before about turncoat experts, so the recent decision in Hawkins v. DePuy Orthopaedics, Inc. 2023 WL 7292164 (D.D.C.

Testimonials

Drug & Device Law

AUGUST 2, 2023

In addition, we blogged about the district court order here. The district court ruled that the three plaintiffs experts flunked the Rule 702 analysis and then granted summary judgment to the defendant because the absence of admissible expert testimony on general causation sunk the case.

Science

Drug & Device Law

OCTOBER 9, 2023

We’ve discussed our Drug and Device Law Blog elder care duties before and how it has educated us about health issues faced by the senior population. Because Dr. Jeret did not employ reliable methods in reaching his general or specific causation opinions, his testimony was excluded.

Vaccine