The FDA Law Blog

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g., l)(1) (e.g.,

Labelling 59

Labelling Communication FDA 59

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.,

FDA 105

FDA Documentation Labelling Communication 105

Pharma Marketing Network

MAY 18, 2025

Certainly, navigating FDA, EMA, or OPDP guidelines can be daunting. Social listening tools can also help identify patient sentiment, gaps in provider communication, or competitive intelligence. A 2024 Accenture study reported that 68% of U.S. FAQs Is digital marketing in pharma compliant with FDA regulations? Absolutely.

FDA 52

FDA Communication 52

Pharma Marketing Network

MAY 18, 2025

Certainly, navigating FDA, EMA, or OPDP guidelines can be daunting. Social listening tools can also help identify patient sentiment, gaps in provider communication, or competitive intelligence. A 2024 Accenture study reported that 68% of U.S. FAQs Is digital marketing in pharma compliant with FDA regulations? Absolutely.

FDA 52

FDA Communication 52

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.

FDA 59

FDA Labelling Communication 59

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.

FDA 59

FDA Communication 59

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Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the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.

FDA 59

FDA Communication 59

European Pharmaceutical Review

APRIL 2, 2025

11-13 Recent reports from US Food and Drug Administration (FDA) authors concluded that AI can usefully be applied to some aspects of ICSR (individual Case Safety Reports) processing and evaluation, but the performance of current AI algorithms requires a human-in-the-loop to ensure good quality. 2024 [cited 2025Feb]. 2024 ;234:3418.

FDA 52

FDA Packaging Communication 52

Pharmaceutical Technology

JUNE 6, 2025

We are going to make this country the hub of biotechnology innovation,” RFK Jr said during a US Food and Drug Administration (FDA) roundtable on cell and gene therapy on 5 June. We may still continue to send you service-related and other non-promotional communications. Bhattacharya centred his remarks around sickle cell anaemia.

52

52

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.

FDA 45

FDA Documentation Communication 45

Pharmaceutical Technology

JUNE 6, 2025

Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. A drug with a recent approval extension in the US, though not the UK, was Supernus Pharmaceuticals’ Qelbree (viloxazine extended-release capsules). ADHD treatments were in the political crosshairs in the US recently.

52

52

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.

FDA 64

FDA Communication 64

The FDA Law Blog

JUNE 5, 2025

Newberger — We have written many posts ( here , here , here , and more) about the impact of the reductions in force (RIFs) on various activities across FDA. We note that the webpage for the Office of Management is still functional, but has not been updated since January 2024.) By Jennifer D.

52

52

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.

Independent Pharmacies 52

Independent Pharmacies FDA Documentation CPhT 52

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.

FDA 64

FDA Communication 64

Pharma Marketing Network

MAY 2, 2025

Over the past five years, the medium has grown exponentially as digital health communication strategies evolved. It offers pharma brands a platform to speak clearly while still complying with FDA communication guidelines. Conclusion and Key Takeaways Healthcare podcasts are reshaping how pharmaceutical brands communicate.

Communication 52

Communication FDA 52

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.

Communication 92

Communication Dosage FDA 92

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.

FDA 52

FDA Communication 52

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.

Hospitals 52

Hospitals Communication FDA 52

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.

Controlled Substances 52

Controlled Substances Communication 52

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 ?

Dosage 98

Dosage Communication FDA 98

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.

Documentation 97

Documentation FDA Hospitals Dosage 97

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.

FDA 52

FDA Communication 52

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.

Health and Personal Care Stores 85

Health and Personal Care Stores Insurance Insurance Coverage Communication 85

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.

Independent Pharmacies 40

Independent Pharmacies Packaging Documentation FDA 40

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.

Communication 40

Communication FDA 40

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?

FDA 52

FDA Packaging Communication Insurance 52

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.

Communication 104

Communication Labelling Hospitals FDA 104

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.

Insurance 64

Insurance Compounding Dosage Communication 64

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.

Communication 52

Communication Patient Care Hospitals FDA 52

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.

Vaccines 59

Vaccines Immunization Medical Schools FDA 59

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.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Communication FDA 52

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.

FDA 52

FDA Documentation Dosage Communication 52

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.

FDA 331

FDA Hospitals Communication 331

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.

Health and Personal Care Stores 84

Health and Personal Care Stores Chemotherapy Immunization Compounding 84

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?

FDA 98

FDA Communication Insurance 98

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.

FDA 98

FDA Vaccines Chemotherapy Communication 98