Information, Manufacturing, Physicals and Provider

Wave of Warning Letters to Foreign OTC Drug Manufacturing Facilities Following Remote Records Requests

FDA Law Blog

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. FDA has resumed on-site inspections of foreign facilities focused on current Good Manufacturing Practices (cGMP) but has continued issuing records requests under Section 704(a)(4), which spurred this latest round of warning letters.

Manufacturing

Manufacturing Electronics IT Physicals

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).

Manufacturing

Manufacturing Engineering Clinic Provider

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

Manufacturing

Manufacturing Electronics Provider Management

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. Registrants may withhold consent or, if given, can withdraw consent at any time.

Management

Management Consulting Provider Physicals

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. Registrants may withhold consent or, if given, can withdraw consent at any time.

Management

Management Consulting Provider Physicals

Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

IT

IT Patient-Centered Patients Clinic

Are You Recall Ready? FDA Expects You to Be

FDA Law Blog

MARCH 20, 2022

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. Almost all recalls are conducted on a voluntary basis by the manufacturer. The Guidance emphasizes that firms need to be “recall ready.”

Electronics

Electronics Manufacturing Provider IT

Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. And one of the parts of that was actually doing physicals for the students and putting them in job placements. So this is a podcast going at the geriatricians and palliative care providers. Hearing aids, you had six big manufacturers of hearing aids.

IT

IT Screening Hospital Clinic

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing

Manufacturing Provider Physicals Electronics

Through Enforcement Discretion, FDA Facilitates Market Entry for New Infant Formulas (For Now); President Invokes Defense Production Act

FDA Law Blog

MAY 19, 2022

If FDA concludes otherwise, proceeding to market with the formula could leave the manufacturer vulnerable to regulatory action. The guidance offers an opportunity that could be of special interest to foreign manufacturers who already market infant formula in other countries and have considered entering the U.S.

Manufacturing

Manufacturing Specialization Physicals IT

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? This hypothesis Played itself out in an interesting way, Ali John 11:15 Thinking about total pain and addressing physical, emotional, social, and spiritual issues.

Illness

Illness IT Patient-Centered Patients

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog

MAY 21, 2024

and its abuse may lead to only moderate or low physical dependence or high psychological dependence. The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. 21 U.S.C. § Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed.

Physicals

Physicals Medical Clinic Emergency Room

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

DECEMBER 7, 2023

What do we do to very concretely provide heat shelters and cool shelters? Ruth: And then to answer your question also about the different providers as far as nurses and physicians and respiratory therapists and pharmacists, most schools of medicine, nursing and all those other fields are including some climate change in their curriculum.

Healthcare

Healthcare IT Education Hospital

Primary Care Digest

Wave of Warning Letters to Foreign OTC Drug Manufacturing Facilities Following Remote Records Requests

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

Trending Sources

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

Urinary Incontinence Revisited: George Kuchel & Alison Huang

Are You Recall Ready? FDA Expects You to Be

Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

Through Enforcement Discretion, FDA Facilitates Market Entry for New Infant Formulas (For Now); President Invokes Defense Production Act

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

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