FDA Law Blog

AUGUST 21, 2023

Investigators also found that the pharmacy sold pseudoephedrine (“PSE”) products but failed to self-certify in violation of the Combat Methamphetamine Act of 2005 (“CMEA”). After employees have been trained, regulated sellers must self-certify through the DEA website provided at the Diversion Control Division Self-Certification Page.

Consulting 52

Consulting Provider IT 52

FDA Law Blog

JUNE 11, 2023

This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.” The BPCA provides FDA with discretion to determine whether to issue, and the appropriate scope of, WRs based on the information that “may produce health benefits” in the pediatric population.

IT 40

IT Provider 40

FDA Law Blog

NOVEMBER 9, 2021

The Draft Guidance provides FDA’s interpretation of the statutory requirement for submission in electronic format. The guidance explains that, when final, 510(k)s would need to be provided as an electronic submission prepared with the current eSTAR template.

Electronics 40

Electronics Physicals Provider Utilities 40

PEMBlog

AUGUST 20, 2024

2005 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. So we need to include pre hospital providers, the emergency medicine teams. I hope that it provided a basic overview and some context. Stratton, M., & Edmunds, K. Extracorporeal Cardiopulmonary Resuscitation.

Patient-Centered 52

Patient-Centered Hospital Patients IT 52

FDA Law Blog

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. There are additionally places to provide attachments for test reports and other supporting documents. When doing so, a pop-up window provides two options.

Provider 52

Provider Electronics IT Complication 52

FDA Law Blog

NOVEMBER 22, 2021

Like the 2005 guidance, this new draft guidance applies to all types of premarket submissions, but now the Agency has specifically added De Novo Classification Requests and Biologics License Applications (BLA). To put the age of the existing guidance into perspective, it was published two years before the first iPhone was released.

Management 52

Management Medical Provider IT 52

The Clinical Problem Solvers

DECEMBER 20, 2021

Remember that more deeply understanding your patients can provide meaning! Dr. Nguyen describes that in his experience, striving for understanding deepens the patient-provider relationship over time and offers fulfillment to him as well as to his patients. [link] California Department of Justice (2021). The Model Minority Myth.”

Community 52

Community Patient-Centered Relationship Healthcare 52

GeriPal

NOVEMBER 17, 2022

We additionally firmly establish that the song How to Save a Life by the Fray was a product of the aughts (2005, to be exact), not the 90’s ): Enjoy! People saw that there were people who needed to have supportive care, didn’t need to have the level of nursing that was provided in nursing homes, and there was money to be made.

Community 97

Community IT Mental Health Medical 97

GeriPal

NOVEMBER 2, 2023

So I did fellowship in 2005. Mike: I became a fellowship director in 2005 and I remember having these same conversations nearly 20 years ago. And one of the things was, “You’re telling us stuff we already know”, and also, “I’m going to critique you in that you didn’t provide any solutions.”

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Board-Certified IT Community Medical Student 91

PEMBlog

DECEMBER 14, 2023

2005 Nov;128(5):3391-7. In the child with more severe symptoms or you’re worried about tracheomalacia, direct laryngoscopy including a diagnostic bronchoscopy in the OR under general anesthesia may provide a more comprehensive look at the Airway and the upper aerodigestive tract. Otolaryngol Head Neck Surg. 2016 Apr;83:78-83.

Diagnosis 52

Diagnosis IT Diagnose Patients 52

GeriPal

SEPTEMBER 12, 2024

I must admit, though, sometimes it just feels off… inauthentic, as if it’s not a genuine desire to improve our lives as health care providers, but rather a metric to check off or a desire to improve productivity and billing by making the plight of workers a little less miserable. That was like 2005. Ishwaria 43:08 Exactly.

IT 111

IT Healthcare Healthcare Professional Patient-Centered 111

GeriPal

DECEMBER 29, 2022

Dealing with conflict in caring for the seriously ill: “it was just out of the question” JAMA 2005. In social work, it’s called self-determination of the client, meaning at the end of the day, I can provide resources to this older adult or to this caregiver, whoever it may be. Journal of Patient Experience.

Family 96

Family Families IT Patient-Centered 96

Pamela Wible MD

JUNE 19, 2025

Open since 2005 her community clinic has inspired Americans to create ideal hospitals and clinics nationwide. I’m just actually providing really good primary health care. In order to heal her patients she first had to heal her ailing profession.

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Clinic Nurse Practitioner IT Medical 246

Physician's Weekly

JUNE 25, 2025

Dangerous changes loomed: To compensate for tax cuts for the wealthy, Trump’s “big, beautiful” bill and budget proposal for fiscal year 2026 threaten to curtail Medicaid, which provides health coverage for people with low incomes and disabilities. About 40% of adults with HIV rely on it for their lifesaving treatments.

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Government Community Family Families 52