FDA Law Blog

AUGUST 26, 2021

In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer. Generally speaking, that recognition has limits, however.

Government 98

Government Manufacturing Individual IT 98

FDA Law Blog

NOVEMBER 29, 2023

Risk-based This guiding principle ensures risk management principles are used to evaluate the individual and cumulative changes over the life of the device. Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change.

Management 115

Management Manufacturing Medical IT 115

FDA Law Blog

JULY 20, 2021

FTC received more than 700 comments in response to the notice of proposed rulemaking from individuals, industry groups, consumer organizations, and members of Congress. FTC concluded that none of the comments provided a compelling basis to change the substantive requirements of the proposed rule.

IT 76

IT Electronics Manufacturing Individual 76

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

My Green Doctor

MAY 3, 2025

The breadth of services provided by modern day medicine is profound. Video recordings were taken as providers administered perioperative routine eyedrops to patients and the eyedrop bottle tips were cultured to assess microbial growth. The product manufacturers and vendors will need to be active partners as well.

Medical 52

Medical Supply Chain Hospital Healthcare 52

FDA Law Blog

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance.

Manufacturing 64

Manufacturing Provider Consulting IT 64

FDA Law Blog

AUGUST 23, 2022

After two negative tests, you should consider a molecular test, or call your healthcare provider. If the third test is negative, you should test again with an antigen test, or get a laboratory molecular-based test, or call your healthcare provider. But the question is, is 80% sensitivity the right place to set the bar?

Individual 97

Individual Clinic Healthcare Provider 97

FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue. Koblitz & Kurt R. Avdel amicus brief).

Manufacturing 105

Manufacturing Provider IT Healthcare 105

Imperial Center Family Medicine

JUNE 2, 2025

The liver manufactures new cholesterol molecules and captures excess from circulation for excretion. Nonetheless, actively cultivating specialized cholesterol-absorbing bacteria provides another route for reducing high blood cholesterol. Specific strains and enzymatic factors influence efficiency.

Family Medicine 52

Family Medicine DO Screening Specialization 52

FDA Law Blog

JULY 22, 2021

Schlanger — Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. Both states’ new requirements will become effective in October 2021 and should be considered as manufacturers prepare for state drug price transparency reporting in 2022.

Manufacturing 52

Manufacturing Asthma Diabetes Families 52

FDA Law Blog

FEBRUARY 13, 2025

Modifications to previously authorized PCCPs can be submitted via a Special 510(k), and eSTAR recommends that the manufacturer submit a clean copy and redline of the PCCP as an attachment. Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.

Manufacturing 71

Manufacturing Management Specialization Provider 71

FDA Law Blog

NOVEMBER 6, 2022

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). If SCOTUS takes up this case, it could have significant and far-reaching implications across the healthcare fraud and abuse landscape. Background.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

NOVEMBER 14, 2022

The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. The facility fee applies to a single manufacturing facility. Size, revenue, and number of finished drug products manufactured at a facility do not affect the OMUFA facility fee.

Manufacturing 52

Manufacturing Individual Management Provider 52

FDA Law Blog

SEPTEMBER 27, 2023

FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. In fact, it seems to us that the Type D meeting provides an opportunity to elicit iterative input from the Agency given that many Type C meetings and even some Type B meetings are being granted as WRO in recent years.

IT 64

IT Provider Manufacturing Clinic 64

FDA Law Blog

JUNE 28, 2021

If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. For the purposes of assessing the annual opiate product registration fee, a “unit” means “the individual dosage form of the particular drug product that is prescribed to the patient. 151.066, Subd.

Hospital 52

Hospital Manufacturing Specialization Medical 52

FDA Law Blog

DECEMBER 12, 2023

Acknowledging concerns about urolithiasis, pet food manufacturers use a range of formulation strategies to make UTH cat food, which have included limiting the magnesium content or formulating it to produce slightly acidic urine. Upper bound of 95% CI ≤ 2.5 CaOx: Mean RSS ≤ 6.0; Upper bound of 95% CI ≤ 2.5 CaOx: Mean RSS ≤ 6.0;

Utilities 59

Utilities Manufacturing Provider Individual 59

FDA Law Blog

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? In an appendix, FDA provides a model “decision check list” for patients. You should place your initials in the location provided next to each item to indicate that you have read and understood the item.

Manufacturing 52

Manufacturing Provider Patients IT 52

FDA Law Blog

JANUARY 2, 2025

The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients. Instead, the exemption from the NTL criteria now applies to an individual food, or a mixed product that is comprised of one or more of the foods recommended by the DGs (i.e.,

Individual 52

Individual Manufacturing Provider IT 52

FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection. Javitt & Jeffrey N.

Telehealth 72

Telehealth Patients Manufacturing Transportation 72

My Green Doctor

MAY 3, 2025

The breadth of services provided by modern day medicine is profound. Video recordings were taken as providers administered perioperative routine eyedrops to patients and the eye drop bottle tips were cultured to assess microbial growth. Let’s build a future where healthcare not only heals—it leads. The use of medications in U.S.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

FDA Law Blog

JUNE 22, 2023

To obtain clearance of an OTC home IVD, a sponsor must provide the usual suite of analytical and clinical validation that would be required for any IVD, demonstrating adequate repeatability, stability, sensitivity, specificity, and so on. By McKenzie E. Cato & Jeffrey N. Gibbs & Allyson B. lay users).

Manufacturing 59

Manufacturing Clinic IT Transportation 59

FDA Law Blog

JANUARY 5, 2025

In either case, if the consumer wrongly enters their information, e.g., and as a result obtains a drug that had they entered the information correctly, they would not have received, does that make the drug misbranded and the drug manufacturer responsible for distributing a misbranded drug? 105288 (Dec.

Provider 59

Provider Healthcare Individual IT 59

FDA Law Blog

SEPTEMBER 12, 2024

The readers of your response at FDA typically include individuals who were not at the inspection, and even if the original investigator is reviewing your response, they may not remember all of the details given the number of other inspections on their plate.

Manufacturing 59

Manufacturing Provider Medical IT 59

FDA Law Blog

OCTOBER 9, 2023

The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year.

Insurance 40

Insurance Manufacturing Patient-Centered Individual 40

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 120

IT Patient-Centered Patients Clinic 120

FDA Law Blog

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,

Supply Chain 52

Supply Chain Individual Provider Patient-Centered 52

FDA Law Blog

OCTOBER 6, 2022

Lewis, Senior Regulatory Device & Biologics Expert — On September 29, 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 gene therapy chemistry, manufacturing, and controls. vector manufacturing for a transgene vector).

Manufacturing 52

Manufacturing Clinic Engineering Individual 52

GeriPal

MAY 5, 2022

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. I’m guessing not.

IT 102

IT Screening Hospital Clinic 102

FDA Law Blog

MAY 7, 2025

The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th

Referral 59

Referral Relationship Government Healthcare 59

FDA Law Blog

JUNE 12, 2023

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. PFI has noted that it is not feasible to develop and label products for an individual state.

Individual 45

Individual Manufacturing Government Illness 45

CDOCS

JUNE 30, 2021

A shape was chosen that provided more incisal embrasures to avoid getting the flat, worn-down look of the incisal edges (Figure 5).</span></p> The multilayered block consists of four layers of zirconia in graduated shades, including an enamel layer, two transition layers and a body (dentin) layer.

Families 40

Families Family Patients Manufacturing 40

FDA Law Blog

JANUARY 26, 2022

In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially. By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming!

IT 40

IT Education Utilities Patient-Centered 40

FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.

Provider 52

Provider Individual IT Manufacturing 52

FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §

Government 59

Government Medical IT Manufacturing 59

FDA Law Blog

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

Patients 52

Patients Clinic Medical Patient-Centered 52