pharmaphorum

AUGUST 31, 2021

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. Beyond the FDA, other institutions have documented what industry standards should look like in assessing RWD in a regulatory context. Furthermore, ECAs are well-documented in the post-approval setting.

Insurance Coverage and Processing

Pharmaceutical Technology

JANUARY 6, 2023

Last week, Novartis announced plans to pay $245 million to end a pay-for-delay legal battle that started in 2018. According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”.

Documentation

RX Note

JUNE 4, 2023

Introduction Once, I received a query from a ward nurse: If a product label mentioned that "Do not store over 25°C", is it fine for us to keep the medication in fridge? What does a cool place on the product label mean? Read the label to know the recommended storage temperature range.

Drug Storage

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. 2018 [cited 2024May]. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. Premier Consulting [Internet].

Drug Development

RX Note

AUGUST 25, 2024

FDA requires the labels of all herbal supplements to include the complete list of ingredients and manufacturers must follow good manufacturing practices (GMP) to ensure that supplements are processed consistently and meet quality standards. Monitor therapy. Avoid in pregnancy.

Diabetes

Ramblings of a pharmacist

JULY 2, 2021

Astute readers will note that Novo Nordisk also sells an “authorized generic” of Novolog®, labeled as “insulin aspart” for a WAC of $279.40. The audits are also pretty much always requesting documentation on the most expensive items dispensed into the plan over the time frame covered by the audit.

Grocery Stores

FDA Law Blog: Biosimilars

JUNE 16, 2023

We expect the Minnesota law to face Commerce Clause, vagueness, and possibly other constitutional challenges, similar to those brought against a generic price gouging prohibition in Maryland that was struck down by the Fourth Circuit in 2018 (see our post here ).

Drug Pricing

European Pharmaceutical Review

NOVEMBER 24, 2022

These include Meditag serialised hologram labels, first introduced in 2005 and found on all registered medicines in Malaysia to help pharmacists and inspectors detect unauthorised and counterfeit product. The fourth version was introduced in 2018. An expansive role for holograms… Meditag serialised hologram labels.

Packaging

PharmaTech

JUNE 23, 2025

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. It builds on drug calculations topics previously described (1), including guidance documents (2–5). Labeling for the primary and secondary labels are determined.

Compounding

LifeProNow

APRIL 9, 2023

These sNDAs are supported by results from the PHAROS trial ( NCT03915951 ), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC.

Adverse Reactions

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).

Health and Personal Care Stores

The Thyroid Pharmacist

JULY 14, 2023

9] A follow-up study done in 2018 (also led by Hofling) assessed the same group of 43 people six years after the clinical trial. Individual doctors may still be able to utilize this therapy with their patients as an “off-label” use. Published 2018 Nov 4. doi:10.1155/2018/8387530 [11] Höfling DB, Chavantes MC, Juliano AG, et al.

Dosage

The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S.

Health and Personal Care Stores

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

Dosage

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night.

HIV Treatment and Prevention Agents

The Thyroid Pharmacist

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In Holy Basil ( Ocimum sanctum ) The anti-inflammatory effects of holy basil (also known as tulsi) have been documented in many in vitro and in vivo studies. Published 2018 Dec 9.

HIV Treatment and Prevention Agents

FDA Law Blog: Biosimilars

JANUARY 13, 2025

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post. By Sophia R.

Documentation

RX Note

FEBRUARY 9, 2025

what you did). Procedures should be developed for the facility, equipment, personnel, preparation, packaging, and storage of compounded preparations to ensure accountability, accuracy, quality, safety and uniformity in compounding.

Documentation

The Thyroid Pharmacist

MAY 12, 2025

Though I dont have the labs to prove that, I did have a beautiful son in 2018. 25] There have also been documented cases of improved egg quality and spontaneous pregnancies following PRP, both naturally and through IVF. 2018 Mar 15;55(3):222-224. [30] Published 2020 Nov 19. Indian J Endocrinol Metab. 2016;20(3):391-398.

Immunity

The Thyroid Pharmacist

NOVEMBER 8, 2024

We saw a decrease in positives from 45 percent in 2017, to only 11 percent in 2018, and then 25 percent in 2019. As such, I re-analyzed the data for the “presence” of parasite DNA labels, and the incidence was substantially higher… 274 total parasites were detected! was also added in January of 2018. Published 2018 Feb 26.

Immunity

FDA Law Blog: Biosimilars

MAY 26, 2025

The gray box at the top of the document at this link shows the change in position. Were not trying to bury the lead here, but the battle of labeling these surgical and drug treatments is a political one. 18-1156, 2018 U.S. Specifically, in United States v. Nagarwala , 350 F. See United States v. Nagarwala , No. Facteau , 89 F.4th

Labelling