FDA Law Blog: Biosimilars

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. 353b(a)(8). 353b(a)(8).

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GMPSOP

MARCH 3, 2024

Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. Store all labels and leaflets in a locked room. How do you control premises to prevent cross contamination?

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Eye on FDA

AUGUST 2, 2022

The characterization of investigative data resulted in a violation related to promotion of an unapproved compound. Violations this year so far were 9 and included risk presentation deficits (3 letters) Superiority Claims and Unsubstantiated Claims (2 each) and Promotion of an Unapproved Drug (1).

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RX Note

MARCH 23, 2023

Introduction Despite the shifting of pharmacy focus to pharmaceutical care, the practice of compounding pharmaceutical formulations remains an essential skill for pharmacists. Product should be labelled clearly and stored as recommended within the formula. Being a drug expert, we are expected to know them all.

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Pharmaceutical Technology

JANUARY 23, 2023

Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients. This lack of options and progression within this IBD patient subpopulation presents a clear unmet need and opportunity.

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Express Pharma

NOVEMBER 1, 2024

Over 70 per cent of these conditions lack a cure and often go unnoticed, presenting a significant opportunity for drug repurposing in India. Streamlined regulatory pathways One of the biggest enablers of drug repurposing is the regulatory framework designed to expedite approvals for already-approved compounds.

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FDA Law Blog: Biosimilars

NOVEMBER 20, 2024

FDA also suggests throughout the draft guidance that information gathering on device materials of construction and the manufacturing process, including chemical additives, processing aids, presence of cohort of concern compounds, etc.,

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Pharmaceutical Technology

DECEMBER 16, 2022

The endometriosis market is expected to grow from $1.05bn in 2020 to $2.72bn in 2030 at a compound annual growth rate (CAGR) of 10.0% The shrinking female population ages 12–54 years in the 5EU and Japan will dampen the extent of growth in diagnosed endometriosis cases.

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Pharmaceutical Technology

JULY 26, 2022

The three major markets (3MM: the US, Germany and the UK) will increase in market size from $128.35m last year to $188.35m in 2031, at a compound annual growth rate (CAGR) of 3.9%. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.

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Quality Matters

MARCH 1, 2024

USP has a long-standing history of healthcare standards including those for compounding preparations that are tailored to meet the unique needs of patients who may not otherwise have access to their medications.

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Ramblings of a pharmacist

SEPTEMBER 27, 2021

As I’ve been walking the shelves, I’ve been musing about the 2D data matrices that are present on every bottle. prefix is 21) Since the enactment of the DSCSA as part of the DQSA (Drug Quality and Security Act), data matrices have been a required component of labeling.

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The Happy PharmD

JUNE 26, 2023

I’ve published several articles and presented poster sessions at national conventions. Furthermore, although the pharmacy labs tried to simulate a retail setting, they stressed compounding, calculations, and consultation. They typed labels, talked to doctors and patients, and focused on the daily number of prescriptions filled.

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Proxsys Rx

DECEMBER 11, 2023

Compounding the problem for manufacturers is the Pharmacy Benefit Managers (PBMs) — third-party companies that function as intermediaries between insurance providers and the manufacturers. Every specialty pharmacy patient you serve should be monitored by a clinic pharmacist.

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European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. The intricate nature of botanical products further compounds the challenge, demanding a paradigm shift in regulatory interpretation and QC standards.

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Proxsys Rx

MARCH 1, 2024

Compounding the problem for manufacturers is the Pharmacy Benefit Managers (PBMs) — third-party companies that function as intermediaries between insurance providers and the manufacturers. Every specialty pharmacy patient you serve should be monitored by a clinic pharmacist.

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RX Note

JUNE 3, 2023

But, what you should know as a pharmacist is never limited to what have been presented here. Who are allowed to dispense or compound any poison for use in medical treatment? What are the legal requirements of labelling on a medication for a dispensed medicine by pharmacist? Familiarise yourself with references below.

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pharmaphorum

DECEMBER 5, 2022

A vast majority of patients diagnosed with CRPC already present with metastases at the time of diagnosis. The findings will be presented at an upcoming medical meeting and submitted to the FDA for regulatory approval in 2023. Prostate cancer is the most frequently diagnosed cancer in men in 112 countries.

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The Thyroid Pharmacist

AUGUST 18, 2023

Benefits and Uses of Curcumin Turmeric’s medicinal benefits can mostly be attributed to compounds called curcuminoids. While most people with Hashimoto’s do have inflammation, only some will present with pain symptoms. Safety and efficacy of curcumin versus diclofenac in knee osteoarthritis: a randomized open-label parallel-arm study.

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GMPSOP

JULY 31, 2023

We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. – Gas Chromatography (GC) Systems (Critical for analyzing volatile compounds). 90% to 110% of the label claim).

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The Thyroid Pharmacist

NOVEMBER 17, 2022

Enzymes are a form of protein present throughout the body. When someone is not properly digesting fats, they will often present with diarrhea, steatorrhea (fat in stools), cramping, bloating, and muscle cramps. Herbal Bitters includes: Ginger : The spicy warmth of ginger comes from gingerol and shogaol, compounds called gingeroids.

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The Thyroid Pharmacist

OCTOBER 25, 2022

Fibrocystic breasts used to be labeled as a disease, but given how common they are, they’re now simply referred to as “fibrocystic breasts.” (7) If symptoms are severe and there are cysts present, a fine-needle aspiration may be performed, which may collapse the cyst and relieve discomfort. (13). Front Immunol. 2019;10:519. 2019.00519.

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GMPSOP

OCTOBER 28, 2023

How to perform sampling in quality control process Sampling is the removal of a presentative portion of a lot to understand the lot’s composition and characteristics. GMP requires that all critical steps of manufacture are reliable or validated. This naturally includes laboratory test methods.

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The Thyroid Pharmacist

OCTOBER 28, 2022

Additionally, probiotics can help with many types of gut disorders, including small intestinal bacterial overgrowth (SIBO) , which is present in over 50 percent of people with Hashimoto’s. Dose: While the label of the product recommends taking two capsules per day, I used higher doses, building up to four capsules, three times per day.

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GMPSOP

JULY 14, 2023

Biological contamination: “Biological contamination” refers to contamination by bacteria, yeasts, molds, viruses, or any other microorganisms that may be present in the product. They should never be topped up, used, or stored without labels and expiry dates.

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The Thyroid Pharmacist

DECEMBER 7, 2022

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).

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The Thyroid Pharmacist

NOVEMBER 15, 2024

While vitamin B9 can be found naturally in foods in the form of folate, it can also be found in the form of folic acid, a manufactured and synthetic version of folate that is present in most bargain-priced multivitamins, as well as often added to processed foods. GLP-1 drugs also carry an increased risk for thyroid tumors, including cancer.

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GMPSOP

APRIL 3, 2023

Sometime these are labelled as the “hidden factory”. – HPLC system calibration – the process of ensuring that an HPLC system produces accurate and reliable separation of chemical compounds. – Ensure systems for archiving of electronic data or notebooks are present. What is GMP documentation?

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GMPSOP

MAY 31, 2024

The validation plan applies to all existing and new drug compounds and registered drug products or active pharmaceutical ingredients (APIs) for clinical use or sale. You should prepare a validation master plan to be presentable as a formal document suitable both as an internal guide and for scrutiny by a member of regulatory inspectors.

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The Thyroid Pharmacist

AUGUST 19, 2022

10) All three are required to be present for an autoimmune condition to manifest. pylori is present. pylori on the GI-MAP (not just what the lab showed to be positive), it ended up being 33 percent of people that had the pathogen present. I hope to share the full results of my review of the test results soon. I’ve had H.

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European Pharmaceutical Review

JUNE 28, 2022

Class I epitopes from non-living vaccines can only be derived by cross-presentation of peptides generated during class II processing of extrinsic viral proteins in antigen presenting cells. presentation, but no robust evidence for this outcome has yet been published. Place exchange and release the peptide from the particle.

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The Thyroid Pharmacist

OCTOBER 7, 2022

Sure enough, she read all the labels on her supplements and in her pantry, and gave her kitchen a stevia-free makeover. Stevia is a natural sweetener derived from the plant Stevia rebaudiana , or “honey leaf,” which contains the sweet-tasting compounds known as steviol glycosides. What is Stevia? What Are the Benefits of Stevia?

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PharmaShots

APRIL 3, 2023

The safety profile was consistent with prior reported studies with no new safety signals & the results will be presented at an upcoming medical meeting & discussed with regulatory authorities The company has a comprehensive clinical development program in EC. APN-1607 & APN-005 for neurodegenerative disease. vs 9.2mos.)

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RX Note

FEBRUARY 23, 2023

Threadworm - Night-time perianal itching is the classic presentation Oral Thrush - Unusual in healthy adults Faecal Incontinence - Unintentional passage of stool Pouching Systems - Available as one-piece or two-piece systems Eye Dry Eye - Evidence of superior efficacy among any of the ophthalmic lubricants is lacking.

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The Thyroid Pharmacist

SEPTEMBER 6, 2023

Furnishings Furniture and carpeting can be a significant source of VOCs (volatile organic compounds), which are emitted as gasses from a variety of both solid and liquid sources. Coffee : Mold toxins can be present in some coffee, and I love Dave Asprey’s commitment to creating mold-free coffee.

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The Thyroid Pharmacist

JULY 8, 2022

Selenium supplementation has also resulted in thyroid improvements in a few studies relating to Graves’ disease, and appears to also have a beneficial effect on Graves’ orbitopathy or ophthalmopathy (which is when antibodies are directed at the receptors presented behind the eyes, leading to a bulging eye appearance). (42). 2017;2017:2549491.

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Pharma in Brief

JANUARY 25, 2023

Such cases typically concern “skinny labels” in which the generic seeks to avoid reference to indications related to the patented use. Combination use : The FC found that a generic manufacturer’s single-compound product would induce infringement of claims to a combination therapy (see here ). The FC’s decision has been appealed.

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The Thyroid Pharmacist

JANUARY 6, 2023

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression.

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