2017 Documentation Dosage 
FDA Law Blog: Biosimilars
DECEMBER 4, 2023
Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” The CDC has advised clinicians to carefully assess increasing total opioid dosage to greater than 50 MMEs per day).
Pharmaceutical Technology
JANUARY 6, 2023
In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”.
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Pharma in Brief
DECEMBER 3, 2023
The most significant change came in the 2006 amendments, which required that a listed patent contain a claim for the approved drug’s medicinal ingredient, formulation, dosage form, or use of the medicinal ingredient. Full actions (2017–present). The first trial was decided in April 2020 (discussed here ). Fast-paced. More efficient?
FADIC
OCTOBER 20, 2023
■ clinical pharmacy services review of treatment chart for appropriate indications drug dosing, dosage form, drug duplication, drug interactions, and drug allergies. ■ All follow-up evaluations and interactions with the patient and his or her other healthcare professional should be included in MTM documentation.
RX Note
AUGUST 25, 2024
A quick question: Do you know the common dosage of St. Fenugreek has been documented to have uterine stimulant effects and has been used in traditional medicine to induce childbirth. 2017 Protecting Consumers from Misleading Online Advertisement for Herbal and Traditional Medicines in Malaysia: Are the Laws Sufficient?,
Pharma in Brief
JUNE 1, 2020
This is the third decision on the merits of an action under the Regulations since they were amended in September 2017. Since both the MS-F202 protocol and MS-F201 results were disclosed in the single Acorda S-1 document, the disclosure requirement had been met. We previously reported on the first and second trial judgments.
Pharma in Brief
JANUARY 17, 2021
Pharmascience obtained approval for a 20 mg strength of its product, Glatect ® , in August 2017. The Court found that the prior art documents cited by Pharmascience ( Pinchasi 2007 and Karussis 2006 ) neither disclosed nor enabled the asserted claims of the 437 Patent. Teva argued that Glatect ® 40 mg will infringe Canadian Patents No.
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