pharmaphorum

OCTOBER 30, 2022

Shares in US biotech Y-mAbs Therapeutics have lost almost a third of their value after FDA advisors unanimously rejected its brain cancer therapy 131I-omburtamab in 16 to 0 vote. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

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FDA Documentation Labelling Immunization 52

The FDA Law Blog

FEBRUARY 7, 2024

In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. Thus, such persons are subject to identification, recordkeeping, and reporting requirements. Also, a DEA Form 452 report must be electronically filed within 15 days after the order is shipped.

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Controlled Substances Documentation 116

ISPE

SEPTEMBER 15, 2022

In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015. The first draft for comments from industry stakeholders was published in 2017 and generated 6000 comments. 12 of February 2020 again received 2,000 comments from public consultation. Barrier System with isolators.

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Documentation FDA 97

The FDA Law Blog

OCTOBER 5, 2022

By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

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FDA Labelling Packaging Documentation 52

The FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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pharmaphorum

DECEMBER 29, 2022

The complaint claims that Par agreed not to launch its generic, in return for Novartis not launching a patent infringement suit and agreeing not to launch its own authorised generic of the drug until 30 March, 2015, giving Par a valuable six months to sell its generic unopposed in the market.

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Specialty Pharmacies Documentation FDA 52

pharmaphorum

JULY 27, 2022

The paper, by a team from Imperial College London, concluded that the FDA gave the go ahead to 95% of the 89 products approved between 2010 and 2019 before EMA, with the Europeans trailing the Americans by a median of 241 days.

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Documentation FDA 98

ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. The US FDA monitors quality, and Kopcha traced changes in regulation of quality over the years. FDA Activities in Support of Quality. Tue, 11/01/2022 - 06:49.

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FDA Insurance Chemotherapy Documentation 98

DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.

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Independent Pharmacies FDA Documentation CPhT 52

pharmaphorum

JANUARY 4, 2022

Everything started to unravel however when a Wall Street Journal investigation in 2015 discovered that most of the tests Theranos claimed to perform on its analyser were actually being performed by standard blood-testing machines.

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Documentation Communication FDA 52

pharmaphorum

SEPTEMBER 13, 2022

The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. 2001– FDA green lights revolutionary treatments. Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001.

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Chemotherapy Immunization FDA Documentation 98

The Checkup by Singlecare

FEBRUARY 16, 2024

10 potential health benefits of NAC Some of NAC’s uses are time-tested and well-documented, like its efficacy in treating acetaminophen overdose. The Food and Drug Administration (FDA) has approved it as a treatment for acetaminophen overdose. Below, we’ll get into the details of NAC’s most intriguing potential benefits.

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Immunization Dosage Packaging FDA 83

Hospital Pharmacy Europe

JUNE 8, 2023

A lack of transparency The importance of setting the primary outcome prior to commencing a study and not deviating from the original protocol, was first highlighted in 1990 by Jay Siegel , a physician and research scientist working for the FDA in the US. Later work simply re-affirmed this finding.

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Documentation Communication Patient Care Hospitals 52

The Checkup by Singlecare

JUNE 14, 2024

A 2015 study found that DHA was much better than EPA on the liver health scale, particularly for preventing tissue scarring caused by NAFLD. Food & Drug Administration (FDA) like prescription drugs. A comprehensive 2023 review of studies suggests that omega-3s may lower a person’s risk for developing liver disease.

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Immunization Documentation Compounding Labelling 105

ISPE

JULY 6, 2023

Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed. Since then, agencies have begun officially adopting the guidance, with the FDA doing so in March 2023.

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Documentation FDA Dosage Pharmaceutical Companies 52

The Spirit Pharmacist

FEBRUARY 21, 2023

The only FDA approved treatment for post-partum depression is a progesterone analogue that must be delivered over a 60-hour IV infusion and appears mildly efficacious. There have been a couple of small case series document LSD use in pregnancy and normal birth outcomes, although these are not high quality or conclusive by any means [23].

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Documentation Compounding Immunization FDA 98

ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. 3 , 4 RAMI integrates all assets, including physical items, software, administrative shell, documents, and personnel. April 2015. Methodology to Define a Pharma 4.0™ It supports the analysis of Industry 4.0

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Packaging Documentation Communication Data Entry 52

The Checkup by Singlecare

JANUARY 25, 2023

Despite medical treatments helping to drop the mortality rate between 2015 and 2019, there’s work to be done in educating the general population about what causes skin cancer and why early detection matters. Of the 99,780 Americans likely to have received a melanoma diagnosis this year, 7,650 are likely to die from it.

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Documentation Insurance FDA 52

pharmaphorum

APRIL 16, 2021

Approval by regulators such as the FDA or EMA, as reported by the regulators themselves. Both the FDA and the EMA rose to the pandemic regulatory challenge very well – addressing the specific COVID treatment and vaccination needs, as well as keeping standard medicines approvals going.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

ISPE

JULY 19, 2023

™ started in 2015 at the ISPE Germany/Austria/Switzerland (D/A/CH) “Plug and Produce” workshop in Basel, Switzerland. Then in 2015, ISPE in Europe founded the Special Interest Group (SIG) Pharma 4.0™, Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance? to a pharma-specific Pharma 4.0™

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Documentation FDA Communication Labelling 98

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry.

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Vaccines FDA Research Laboratories Documentation 128

The Thyroid Pharmacist

JULY 29, 2022

This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. About 10 percent of those in my 2015 survey of 2,232 people with Hashimoto’s said that mold was a trigger for them… and those were only the ones who had already uncovered the issue. doi:10.1155/2015/760689. 2015 Jan 1;20:872-91.

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Health and Personal Care Stores Compounding Immunization Labelling 52

The Checkup by Singlecare

DECEMBER 12, 2024

manufactures, was approved by the Food and Drug Administration ( FDA ) in August 2015 for hypoactive sexual desire disorder ( HSDD ) in pre-menopausal women. Plans may have criteria to be met to offer coverage, including specific documentation from the provider to confirm the patient is pre-menopausal with a diagnosis of HSDD.

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Insurance Insurance Coverage Documentation FDA 52

ISPE

SEPTEMBER 11, 2023

1 May 2015. Journal of Biotechnology 213 (2015):120–30. Rockville, MD: US Pharmacopeial Convention, 2015. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/examples-accepted-emerging-technologies 26 Eisner, D.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

JULY 5, 2023

7 A critical feature of the ETP is representation from all relevant FDA quality assessment and inspection programs, from early engagement with stakeholders through application submission and assessment. 13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter.

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FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

SEPTEMBER 11, 2023

Regulatory Background and Cleanroom Air Velocity In 2015, the authors of the Concept Paper on Revision of Annex 1 decided to harmonize the regulatory framework globally, including established methodologies such as those from the International Organization for Standardization (ISO). Published 2 February 2015. m/s up to 0.54

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Documentation FDA Packaging Communication 52

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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Documentation FDA Communication Packaging 52

The Thyroid Pharmacist

JUNE 14, 2023

A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! doi:10.1155/2015/940241 [16] Stanisławska IJ, Figat R, Kiss AK, Bobrowska-Korczak B. January 8, 2015. His wife had Hashimoto’s.) Case Rep Endocrinol. 2015;2015:940241. 2022;14(6):1225.

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Health and Personal Care Stores Immunization Documentation Compounding 111

ISPE

JULY 6, 2023

1 , 4 A Retrospective Journey In 2015, Vertex’s Orkambi was the first approved drug produced under a CM process for the treatment of cystic fibrosis. An average of two approved drugs via CM per year since 2015 shows that progress has been slow but steady and that interest in CM and its potential has been sustained.

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HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

The Thyroid Pharmacist

JANUARY 20, 2023

In 1998, the Food and Drug Administration (FDA) defined an adaptogen as a new kind of metabolic regulator that has been proven to help in environmental adaptation and to prevent external harms. A 2015 study published in Endokrynologia Polska found the Epstein-Barr virus in the thyroid cells of 80 percent of people with Hashimoto’s and 62.5

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HIV Treatment and Prevention Agents Immunization Compounding Documentation 98

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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Documentation FDA Hospitals Dosage 97