FDA Law Blog

FEBRUARY 9, 2024

By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ).

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Clinic Manufacturing Provider Electronics 105

PEMBlog

FEBRUARY 7, 2024

Just look at the rash – then scroll down to reveal the diagnosis. That’s it. And oh yeah, she did spend time in a hot tub during a recent trip. The nodules on the platter surface of the feet are painful. She is systemically well appearing. It’s Pseudomonas Hot-Foot Syndrome! This malady is characterized by the acute onset in children of exquisitely tender plantar nodules and a benign, self-limited course.

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Diagnosis IT 98

Evergreen Family Medicine

FEBRUARY 8, 2024

Written By: Kolby Wade, CNM It can be overwhelming to decide on a type of birth control. There are so many options that are used in many different ways and have potentially different effects. Birth control can be used for multiple reasons; the most obvious is avoiding pregnancy, but hormonal contraception can also be used to help manage bothersome menstrual cycle symptoms throughout a woman's entire life.

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Management IT 40

The Clinical Problem Solvers

FEBRUARY 5, 2024

[link] Episode description Reza and Rabih discuss a case of a patient with profound fatigue Student discount [link] IMG discount Use coupon code RLRIMG at check out [link]

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Patients 52

FDA Law Blog

FEBRUARY 4, 2024

By Steven J. Gonzalez & Gail H. Javitt & Allyson B. Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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Clinic Management Medical IT 59

PEMBlog

FEBRUARY 9, 2024

Just look at the rash – then scroll down to reveal the diagnosis. That’s it. This child was placed on Amoxicillin for acute otitis media and this rash developed after 9 days of treatment. The child has fever and swollen feet as well. It’s Serum Sickness Like Reaction! This is a delayed allergic reaction to an antibiotic. Another name would be Urticaria Multiforme with systemic symptoms and joint involvement.

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Diagnosis Family Families Hospital 52

GeriPal

FEBRUARY 8, 2024

Summary Transcript Summary In 1982 Eric Cassell published his landmark essay: On the Nature of Suffering and the Goals of Medicine. Though his narrow definition of suffering as injured or threatened personhood has been critiqued , the central concept was a motivating force for many of us to enter the fields of geriatrics and palliative care, Eric and I included.

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IT Family Families Physicals 137

FDA Law Blog

FEBRUARY 6, 2024

By Kurt R. Karst — The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations invited Hyman, Phelps & McNamara, P.C. PM Counsel John Claud to testify yesterday about FDA’s foreign inspection program. Mr. Claud frequently counsels foreign and domestic clients on issues relating to inspections and cGMP remediations. We’ve blogged previously on the troubles FDA has faced ramping up its foreign inspections program after the pandemic.

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Provider Manufacturing Government IT 52

PEMBlog

FEBRUARY 8, 2024

Just look at the rash – then scroll down to reveal the diagnosis. That’s it. This is a baby with swollen, erythematous skin of the chest wall. It’s Neonatal Mastitis! This is a skin and soft tissue infection of the breast tissue in a newborn. The treatment is directed towards S. aureus and you should never squeeze or incise this tissue in the ED.

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Consulting Diagnosis Illness IT 52

PEMBlog

FEBRUARY 6, 2024

Just look at the rash – then scroll down to reveal the diagnosis. That’s it. Nothing fancy. It’s Enterovirus! This rash is from enterovirus. It often looks dramatic like this in teenagers – and it can be painful. Notice the scabbed lesions that are present on the palms. It’s like hand, foot and mouth – but this is the adolescent presentation.

Diagnosis 52

Diagnosis IT 52

PEMBlog

FEBRUARY 5, 2024

Just look at the rash – then scroll down to see the answer. That’s it. Nothing fancy. It’s Herpetic Whitlow! Herpetic Whitlow is a condition that often is seen in thumb suckers and is due to herpes simplex virus. The lesions are painful, and should not be confused with abscesses. Attempting an I&D can only make it worse. This may be an isolated finding or part of a primary outbreak with rash elsewhere, fever, and other systemic symptoms.

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IT 52

FDA Law Blog

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. With regulations varying significantly from one state to another, companies in these sectors often find themselves immersed in a labyrinth of compliance requirements.

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Consulting Manufacturing Government Provider 45

FDA Law Blog

FEBRUARY 7, 2024

By John A. Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. As stated in the press release , this was the fourth largest civil penalty settlement under the CSA and, ironically, did not involve the sale or distribution of any contr

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Government Electronics Education Individual 116

FDA Law Blog

FEBRUARY 5, 2024

By Deborah L. Livornese — Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. As we described in our blog post here , the Food and Drug Omnibus Reform Act (FDORA) enacted at the end of 2022 adds new statutory obligations related to the development of diversity action plans by sponsors of certain device and drug clinical trials, and requires FDA to issue guidance.

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Clinic Medical Provider Management 59