The FDA Law Blog

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant. By John W.M.

FDA 64

FDA Packaging Communication 64

The FDA Law Blog

NOVEMBER 30, 2023

The speaker faculty of top FDA regulatory authorities will share critical insights on foreign and domestics inspections, digital health, DOJ’s compliance guidelines, and data privacy, among many other topics. The conference will also include its annual panel discussion with FDA’s Center Compliance Directors.

FDA 59

FDA Communication 59

Pharmaceutical Technology

MAY 10, 2023

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. Gilead markets both Truvada and its successor Descovy.

Pharmaceutical Companies 105

Pharmaceutical Companies Pharmaceutical Companies FDA 105

Druggist

APRIL 3, 2021

The legal classification of topical diltiazem . Topical diltiazem: legal classification. Diltiazem topical cream may be offered for the management of anal fissure together with other recommendations, for example, the use of simple analgesics like paracetamol or ibuprofen. Diltiazem cream: legal classification.

81

81

The Checkup by Singlecare

DECEMBER 4, 2023

Through it all, we provided informative health and wellness news on a range of topics, such as nutrition advice, how to manage weight loss medications, and tips for safely buying prescription drugs in other countries. It’s been an eventful 12 months, and we’ve covered a lot of topics since January. Read the full article here.

Insurance 105

Insurance 105

Pharmaceutical Technology

JULY 6, 2022

In a press statement, CureVac said: “CureVac does not seek an injunction nor intend to take legal action that impedes the production, sale or distribution of Comirnaty by BioNTech and its partner Pfizer.”. Topic sponsors are not involved in the creation of editorial content.

Vaccines 72

Vaccines 72

Board Vitals - Pharmacist

NOVEMBER 28, 2022

The following topics are on the USMLE Step 1 : . Advanced Topics in Anesthesiology 50%. The ABA ADVANCED Exam consists of 200 multiple choice questions that cover the following topics: . The Medical College Admission Test (MCAT) is a required exam for those looking to enter medical school. USMLE Step 1.

Medical Schools 98

Medical Schools Communication Patient Care Immunization 98

pharmaphorum

AUGUST 26, 2020

“They designed pre-printed prescription forms with multiple options of pre-determined categories of medical conditions with the physician marking boxes for medications, often high-dollar cost topical creams and ointments,” claims Humana and its legal counsel.

Insurance 121

Insurance 121

Pharmaceutical Technology

APRIL 6, 2023

.” Foley Hoag served as legal counsel to Ginkgo for the transaction, while Ropes & Gray was the legal advisor to StrideBio. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

Board Vitals - Pharmacist

SEPTEMBER 1, 2022

Tests knowledge of legal and ethical implementations for healthcare and technology; nonpharmacologic intervention and treatment selection; pharmacotherapeutic intervention selection; regulatory guidelines; and APRN scope and standards. Implementation. Evaluation. What subjects are covered on the new FNP Exam?

Immunization 52

Immunization 52

Druggist

MARCH 17, 2021

The legal classification of lymecycline. The legal classification of lymecycline. Patients diagnosed with mild to moderate acne are usually prescribed a topical (applied to the skin) retinoid, for example, adapalene on its own or in combination with benzoyl peroxide. Alternatively, a topical antibiotic can also be prescribed.

59

59

Pharmaceutical Technology

MAY 17, 2023

While negotiating drug prices is common practice in other major markets, CMS had not previously held the legal authority to do so. Insulin affordability has continued to prove a hot button topic as major pricing reforms are on the way.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA 52

InCrowd

JUNE 12, 2023

After taking report, I noticed the legal name attached to her medical record was not consistent with what I perceived as her gender expression. As I continue to absorb wisdom from my older and more experienced colleagues, I’ve pushed myself to start conversations about topics like pronouns and gender-affirming care.

Medical Records 52

Medical Records Compounding 52

Druggist

JULY 29, 2020

Steroid cream (also known as corticosteroid cream) is a topical medication (applied to the skin) used as anti-inflammatory preparation used in the treatment of various skin conditions including irritant and contact dermatitis (sore, red and swollen skin), insect bites and mild to moderate eczema. Scenario: Topical treatment.

72

72

OctariusRx

FEBRUARY 6, 2023

Whenever I have an opportunity to speak on this topic, I make it a point to remind everyone to expect diversion and develop systems before it happens. The topic of properly handling controlled substances is always at the forefront of any discussion on compliance, but it extends far beyond just a paper trail. Legal liability.

Controlled Substances 68

Controlled Substances Documentation Hospitals Patient Care 68

Druggist

JANUARY 21, 2021

Paracetamol can be purchased in shops and supermarkets (quantity limited to two-pack of 16 tablets) or from the pharmacy with maximum legal quantity sold for up to 100 tablets or capsules. Topical ibuprofen (ibuprofen gel). See ibuprofen section below for comments on topical ibuprofen prescribing. Ibuprofen (topical).

Compounding 92

Compounding 92

The FDA Law Blog

APRIL 25, 2023

However, FDA’s legal standing to insist on cybersecurity features, especially within the substantial equivalence paradigm, has been questionable. Now, with explicit statutory authority, FDA’s push for cybersecurity has a firm legal footing. We have recently blogged on this topic (“ Is my software a medical device? ”).

FDA 105

FDA Documentation Labelling Communication 105

The FDA Law Blog

NOVEMBER 2, 2023

In short, Voluntary Consensus Standards (VCS) are intended to be exactly what the name conveys – standards that are adopted by consensus and are not mandatory (not legal or regulatory requirements). These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

FDA 59

FDA Packaging Documentation Labelling 59

pharmaphorum

DECEMBER 22, 2021

Patient centricity and patient engagement have been hot topics in pharma for some time – but buzz words do not always translate into concrete action. Legal requirement, ethical duty: How to develop compliant, useful lay summaries. As part of our 2021 in Review series, we look back over some of these developments. “We

Documentation 105

Documentation 105

The FDA Law Blog

APRIL 21, 2024

For purposes of the preceding sentence, the term “business day” means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under section 6103 of title 5. which brings us to the topic of this post. On occasion, PTE applicants try to fight a PTO determination that the application was untimely.

Labelling 59

Labelling FDA Controlled Substances 59

ISPE

FEBRUARY 14, 2023

Know the key topics. Recognize the agency’s legal authority and constraints. In the guide “ A Guide to Writing Public Interest Comments Using Economic Analysis ,” Jerry Ellig (Oct 2014) presents six fundamental actions that will give comments the maximum advantage: Understand the regulatory process.

Documentation 52

Documentation Communication 52

ISPE

DECEMBER 6, 2022

Legal and/or compliance issues due to. The same holds for whether we are paper based or digital; we should understand that documentation, in any form, should be kept professional and on-topic. iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry.

Documentation 52

Documentation Communication 52

Hospital Pharmacy Europe

JANUARY 18, 2023

3 A typical treatment pathway involves emollients and topical corticosteroids (first line), topical calcineurin inhibitors (i.e., Dupilumab was the first therapy to be approved for moderate-to-severe AD that does not respond to topical therapies based on large, randomised, double-blind placebo-controlled clinical trials.

Hospitals 52

Hospitals Medical Records Documentation Pharmaceutical Companies 52

ISPE

JULY 26, 2023

With a focus on supply chain resiliency and sustainability, the conference sessions cover a wide range of topics critical to the success of pharmaceutical companies. Attendees will gain a comprehensive understanding of the cultural, legal, and operational considerations necessary to navigate emerging markets effectively.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

OCTOBER 7, 2021

Promoted by the Smith Kline Foundation, the project is the combined result of a working group consisting of approximately 40 experts from the clinical, academic, regulatory, medico-legal, industrial, and health economy fields, as well as Patient Association representatives and digital health innovation organization Healthware Group.

Insurance Coverage 52

Insurance Coverage Insurance Communication 52

pharmaphorum

NOVEMBER 1, 2021

That’s according Carinne Brouillon Head of Human Pharma and member of the Board of Managing Directors at Boehringer Ingelheim, who spoke during a fireside chat on the topic, held at the online Reuter’s Events Pharma 2021 event. This removes barriers around scientific and legal language, and facilitates engagement.

Communication 84

Communication 84

The Checkup by Singlecare

OCTOBER 11, 2023

Pregnant women can also safely apply a topical menthol, like Vicks VapoRub, to relieve congestion and coughing. Food & Drug Administration (2023) Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine , U.S.

Mayo Clinic 106

Mayo Clinic Immunization FDA Compounding 106

The Spirit Pharmacist

DECEMBER 7, 2021

However, the points about having little awareness of positive research or carrying stigmatic attitudes as well as simply not having the time for the kind of conversation that does the topic justice in their workflow are all valid. compassionate use of a psychedelic in persons that have tried and failed existing options) and what is legal.

Medical Records 52

Medical Records Documentation Insurance 52

Druggist

JANUARY 15, 2021

Paracetamol: legal limits on purchase. Topical product alternative to paracetamol . Topical gels can be useful as alternatives to paracetamol. The topical gel may be suitable for some customers for whom oral ibuprofen is not recommended. . Flexiseq Osteo Topical Gel. Common conditions include: . nerve pains .

52

52

The FDA Law Blog

FEBRUARY 27, 2023

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies.

Controlled Substances 59

Controlled Substances FDA Documentation Labelling 59

ISPE

NOVEMBER 23, 2022

The Regulatory Challenges in ATMPs session provided a diverse set of perspectives on regulatory/quality topics as it pertains to late stage/commercial ATMPs, primarily autologous cell therapy.?The Melanie Eacho, Cell Therapies Branch Chief within the Office of Tissues and Advanced Therapies (OTAT) , US FDA/CBER.

FDA 52

FDA Documentation 52

Druggist

APRIL 20, 2021

Legal classification. The condition was defined as severe when 10% or more of the skin was affected and patients failed to get a response from standard treatment, for example, the use of antihistamine tablets and topical steroids. Montelukast vs antihistamines: legal classification. Montelukast: mechanism of action. Conclusion.

Compounding 52

Compounding 52

DiversifyRx

APRIL 27, 2023

Unless you have been hiding under a rock, you have probably noticed that weight loss drugs are a hot topic. At least the doctor or patient will know you aren’t being rigid to suit yourself, but there is a clinical/legal/practical reason why.

Compounding Pharmacies 52

Compounding Pharmacies Compounding Independent Pharmacies Packaging 52

The Checkup by Singlecare

JANUARY 18, 2024

Examples of nitrates include: Any form of nitroglycerin , such as sublingual (placed under the tongue) tablets, oral capsules, topical ointment, or skin patches Isosorbide dinitrate Isosorbide mononitrate This also includes illicit drugs called “poppers,” such as amyl nitrate, amyl nitrite, or butyl nitrate.

Dosage 52

Dosage FDA 52

Hospital Pharmacy Europe

AUGUST 22, 2023

His first post was as a lecturer at the University of Bradford in West Yorkshire where he was involved in several projects based on pharmaceutical care, which he describes as being a hot topic at the time. million residents of Hong Kong.

Vaccines 96

Vaccines Community Pharmacies Hospitals Communication 96

ISPE

JULY 10, 2023

Knowledge base search: A topic can be explored and described in various tones from simple understanding to deeper and expert information. The chat functionality can be used to elicit references on this topic; however, these “references” may be poor quality or may be fabricated. Can you also provide a test case for your class?”

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Viseven

MAY 15, 2023

HCPs can share their professional and personal opinions on the brand, products, or any other e-detailing topic with a drug company. Powered by modular content, eWizard allows your company to reuse pre-approved content blocks and tremendously simplify medical, legal, and regulatory affairs for e-detailing. Quality of E-detailing.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Communication Patient Care 52