The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. However, FDA’s legal standing to insist on cybersecurity features, especially within the substantial equivalence paradigm, has been questionable. It applies whether the software is the entire device (i.e.,

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The FDA Law Blog

AUGUST 11, 2024

on July 17, 2024 for a social media post published by Instagram influencer Brittany Mahomes (who has 2 million Instagram followers) about AUVI-Q (epinephrine injection, USP) that “entirely omit[ed] all risk information” about the drug. August 2024 Untitled Letter to Mirati Therapeutics Inc.

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The FDA Law Blog

OCTOBER 1, 2024

District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals). In January 2024, the U.S. II, § 2, cl.

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The FDA Law Blog

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. By Véronique Li, Senior Medical Device Regulation Expert & Deborah L.

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The FDA Law Blog

APRIL 30, 2024

Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , which included some changes over the existing guidance which could have a negative impact on future pre-submissions.

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The FDA Law Blog

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

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DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.

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The FDA Law Blog

MARCH 11, 2024

Mullen — On February 20, 2024, FDA issued a letter to the medical device industry ( link ) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in premarket submissions. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Allyson B.

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The Checkup by Singlecare

FEBRUARY 1, 2024

Food and Drug Administration (FDA) to treat opioid use disorder and alcohol use disorder. Communicating openly with your healthcare team about all medical conditions you have and medications you take is the best way to identify potential naltrexone interactions. It comes as an oral tablet and intramuscular (IM) injection.

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The FDA Law Blog

DECEMBER 7, 2023

In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing.

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pharmaphorum

SEPTEMBER 29, 2022

A digital patient monitoring tool developed by UK company CyberLiver has been given a breakthrough designation by the FDA for out-of-hospital management of patients with cirrhosis at risk of complications. The post Digital tool cuts hospital readmissions in cirrhosis patients appeared first on.

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The FDA Law Blog

MAY 10, 2023

In addition, concerning any practitioner-patient telemedicine relationships that have been or will be established up to November 11, 2023, all telemedicine flexibilities concerning prescribing of controlled substances established during the COVID-19 PHE will also be extended for one year – through November 11, 2024. 1307.41and 42 C.F.R.

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The Checkup by Singlecare

JULY 20, 2024

The oral medication, approved by the Food and Drug Administration ( FDA ) in 1971, works as an antimicrobial , killing the bacterial cells that caused the UTI. A 2024 comparative study found that cephalexin for the treatment of UTIs had a failure rate of 8.3% UTIs are more common in women than men. Is cephalexin good for UTIs ?

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Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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The Checkup by Singlecare

MAY 1, 2024

The FDA has approved these devices for mild to moderate hearing loss. In 2024, the household income limit to qualify is under $27,180 for an individual or under $36,620 for a two-person household. In 2024, this is $30,120 for an individual and $40,880 for a couple. There are a few options to consider.

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Pharma Marketing Network

JANUARY 29, 2025

For patients, omnichannel marketing is about seamless communication. Regulatory bodies like the FDA and EMA enforce stringent advertising guidelines, ensuring that pharma companies maintain transparency and ethical marketing practices. Meeting HCPs where they are, whether its in a clinical setting or browsing research articles online.

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DiversifyRx

NOVEMBER 24, 2023

While DSCSA (the Drug Supply Chain Security Act) enforcement is postponed until November 2024, it is critical to move forward in becoming compliant sooner rather than later. When regulators, such as the FDA, request information about a specific drug product, your pharmacy must be able to promptly provide the necessary traceability data.

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Roots Analysis

JANUARY 17, 2024

Renowned figures such as Elon Musk and Oprah Winfrey openly discuss their experiences with the drug, sparking interest beyond its FDA-approved use. Global Expansion and Negotiation Challenges for Eli Lilly Eli Lilly’s future plans encompass the expansion of its weight-loss drug Mounjaro to new countries in 2024.

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European Pharmaceutical Review

MARCH 28, 2024

FDA is expected to provide initial feedback on the data submitted by July 2024, with further data to be collected and analysed over the next two years. What is the main reason submission of the DVA qualification to FDA is significant for future clinical trials?

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Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Samsung Bioepis and Organon previously stated that Hadlima's interchangeability data should be ready in 2024. While small molecule drugs can be remade into identical generics, biologics are more complex.

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PharmaShots

FEBRUARY 22, 2023

Some of its FDA-approved competitors include: Patents7 Eli Lilly carries big expectations from Trulicity to boost its revenue. Those with Medicare or Medicaid coverage are not eligible. Trulicity Competitors6 There are many other alternative types of diabetes medications present in the market that gives tough opposition to Trulicity.

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PQA

OCTOBER 3, 2023

PQA offers a competitive Advanced Pharmacy Practice Experiential (APPE) Rotation for pharmacy students, which provides experiential learning opportunities in non-profit association management, medication use quality education, communications, research and performance measurement. Applications for the 2024-25 year are now being accepted.

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Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995. GlobalData is the parent company of Pharmaceutical Technology.

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pharmaphorum

APRIL 19, 2022

I think the most important thing is making a good team and also good communication within that team is very important. RudaCure’s leading product in development RCI001, is an ophthalmic solution for the treatment of Dry Eye Disease looking to start Phase 1 trials in South Korea and Phase 2 FDA clinical trials by 2023.

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ISPE

SEPTEMBER 8, 2023

In addition, this article provides an explanation of the purpose and expected outcomes from the survey, subsequent plans for communicating the results from the survey across ISPE, and development of concrete proposals to address the sources of challenges and barriers to innovation. 22 June 2023. link] 16 US Food and Drug Administration.

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IDStewardship

APRIL 14, 2024

Article Posted 14 April 2024 What is Clostridioides difficile ? These advancements are evidenced by the two FDA-approved FMT products available for rCDI prevention: Rebyota (Fecal Microbiota, Live-jslm) and Vowst (Fecal Microbiota Spores, Live-brpk). Rebyota, a solution delivered via enema, was the first FMT product to be FDA-approved.

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The Thyroid Pharmacist

SEPTEMBER 20, 2024

Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. 82] Many of them do so by helping the gut to communicate with the central nervous system, essentially retraining it to move more efficiently. freece.com.

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The Checkup by Singlecare

MARCH 8, 2024

On March 5, 2024, the U.S. Food and Drug Administration (FDA) approved the first over-the-counter (OTC) continuous glucose monitor (CGM). Especially for people who are managing diabetes, the Stelo GCM should be used in communication with a healthcare team. Produced by DexCom, Inc., When will Stelo be available?

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). The company aims to then increase supplies in 2024. Please check your email to download the Report.

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The Checkup by Singlecare

AUGUST 13, 2024

Saxenda and Wegovy are injectable medications approved by the Food and Drug Administration (FDA) for the treatment of obesity and obesity-related health conditions. It’s also important, though, to communicate with your healthcare provider about any side effects you’re experiencing so they can work with you to find the right dose.

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The FDA Law Blog

NOVEMBER 17, 2022

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S. An independent third party (or parties) will conduct assessments of the TAP Pilot beginning in FY 2024. See Announcement.

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The FDA Law Blog

JUNE 14, 2023

In the ever-changing landscape of medical device development, FDA is touting steps it is taking that it says will enhance efficiency, foster innovation, and address key challenges faced by developers. It remains to be seen how FDA would define and actually implement the role of a TAP Advisor.

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The FDA Law Blog

JULY 9, 2024

To encourage the development of such guidance, Congress directed FDA to issue a draft guidance not later than 12 months after the date of FDORA’s enactment and to finalize such guidance not later than 9 months after closing the comment period. intended use population. population in light of the U.S. role in global health.

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The FDA Law Blog

NOVEMBER 21, 2022

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S. An independent third party (or parties) will conduct assessments of the TAP Pilot beginning in FY 2024. See Announcement.

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Pharmaceutical Technology

MARCH 29, 2023

In June 2020, the FDA gave ATX01 an orphan drug designation in erythromelalgia. The company expects to have data from both trials ready in mid-2024, says Thiroloix. Talks for this fundraise will likely start at the beginning of 2024, and the aim is to raise a significantly higher sum than in the previous rounds, confirms Thiroloix.

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European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Recommendations were also published earlier this year for all stakeholders in the pharma supply chain.

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PQA

DECEMBER 15, 2022

Data Infrastructure and Interoperability – Pharmacy performance measures require the use of innovative technology solutions to capture and communicate data beyond just prescription claims and dispensing information.

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