The FDA Law Blog

OCTOBER 3, 2022

Mr. Bawduniak alleged that, between 2009 and 2014, Biogen paid illegal kickbacks to its largest prescribers to induce them to prescribe the company’s multiple sclerosis drugs, Avonex, Tysabri and Tecfidera, and discourage them from prescribing newer competitor products. This lawsuit was brought to the U.S. See United States ex rel.

Documentation 105

Documentation 105

ISPE

SEPTEMBER 15, 2022

First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. Annex 1 of the EC GMP Guide " Manufacture of Sterile Medicinal Products " has a long history. In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015.

Documentation 97

Documentation FDA 97

Pharmaceutical Technology

OCTOBER 5, 2022

In 2009, former Biogen employee Michael Bawduniak filed a lawsuit claiming that Biogen had violated the False Claims Act and the Anti-Kickback Statute by providing millions of dollars to healthcare providers (HCPs) as an incentive to prescribe three of its multiple sclerosis (MS) drugs.

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 59

pharmaphorum

DECEMBER 28, 2022

In 2018, over 60% of all new molecular entities came from smaller biopharma firms, compared with just over 30% in 2009. In the last 15 years, there has been a noticeable shift towards many prominent players effectively outsourcing innovation to start-ups due to the increasing cost of R&D.

Documentation 119

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 119

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC.” Article 63 EMA (29 January 2020).

Packaging 98

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 98

The FDA Law Blog

JANUARY 15, 2024

This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA. Nor did FDA give notice that favored product manufactures had to submit robust scientific studies on flavored cigarette products.

FDA 115

FDA Documentation 115

pharmaphorum

NOVEMBER 27, 2020

Teva said in a statement: “The Commission started investigating this agreement in December 2009. Examples included a “lucrative” supply contact earning Teva at least five million euros in profits, even though Cephalon could cover its needs without the additional supplies.

Packaging 52

Packaging Documentation 52

pharmaphorum

DECEMBER 17, 2020

As the co-founder of the biopharma company, Raab has been focusing on advancing patient care for kidney disease since 2009. While Ardelyx awaits FDA approval for Tenapanor, it is moving forward with regulatory approval internationally and has filed documents with the European Medicines Agency (EMA).

FDA 104

FDA Documentation Patient Care 104

Impact Pharmaceutical Services

AUGUST 21, 2022

In 2009, IMPACT (now part of Syner-G BioPharma Group) was contracted by a mid-size global pharmaceutical company to prepare 2 Phase 3 clinical study reports (CSRs) for a biologic agent for the treatment of Crohn’s disease. Download a PDF of this case study. Establishment of a Long-Term Medical Writing Partnership.

Documentation 40

Documentation Pharmaceutical Companies Pharmaceutical Companies 40

The Checkup by Singlecare

DECEMBER 1, 2023

From bolstering our immune system to promoting bone health and potentially warding off chronic diseases, the benefits of vitamin D are vast and well-documented. The Journal of Steroid Biochemistry and Molecular Biology (2009) Country of origin labeling consumer information [PDF] , U.S.

Labelling 93

Labelling Mayo Clinic FDA Immunization 93

European Pharmaceutical Review

DECEMBER 20, 2023

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. Figure 2: European Commission proposed changes to regulatory data protection periods for non-orphan and orphan drugs (Source: L.E.K) What are the latest amendments?

Labelling 98

Labelling Documentation 98

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation 52

Documentation Dosage Packaging Communication 52

The Thyroid Pharmacist

JUNE 16, 2023

Black seed oil has likely been used as a medicinal herb for 3000 years or more, and its use has been documented in Ayurveda, Unani, Tibb, Siddha, and other systems of medicine. [4] Published 2009 Mar 10. [15] 2009; 1(2); 143-149. [22] Int J Physiol Pathophysiol Pharmacol. 2009;1(2):143-149. 22] Shokri H. Avicenna J Phytomed.

Compounding 116

Compounding Dosage Immunization Insurance 116

ISPE

JANUARY 11, 2023

5 It includes cleaning validation master plan, product risk assessment, utility and equipment readiness, analytical method readiness, sampling site selection/grouping, standard operating procedures, validation protocols, execution of validation protocols, personnel training, and the validation documentation package. link] 4 Pluta, P.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

PharmaShots

JUNE 2, 2023

THYNK assists in patient eligibility & pre-approval checks adding to it medical necessity & documentation checks. Formed as a spin-off into a standalone company in 2019, the firm has a proven legacy as a center of excellency in the healthcare RCM Tech domain since its inception in 2009.

Health and Personal Care Stores 40

Health and Personal Care Stores Insurance Coverage Insurance Medical Records 40

The People's Pharmacy

MAY 8, 2023

There have been problems with records in the past: deceit, falsification of documents and even outright fraud. In her Fortune article Katherine Eban noted that: “…the company’s misconduct continued well into 2009 even after the FDA restricted the company’s activities.” “For Here’s the kicker.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 4 (2009): Online Exclusive: [link] 10 US Food and Drug Administration. link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 m/s up to 0.54 McGarvey, and T.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

SEPTEMBER 8, 2023

Published August 2009. en/documents/other/european-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf 11 European Medicines Agency. [link] 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Published January 2023. 22 June 2023. EMA/321483/2020.

FDA 52

FDA Documentation Dosage Communication 52

ISPE

JULY 6, 2023

This document is approved by the firm’s board of directors and sets the tone for risk-taking at the company by key risks and setting risk tolerances for how much risk the board is willing to take across all business activities. This document catalogs and summarizes the various risks to the company. April 2009. November 2022.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 7, 2023

Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Published August 2009. Press Release. 30 November 2022. link] 6 European Medicines Agency. Committee for Medicinal Products for Human Use. 27 January 2022.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

The Thyroid Pharmacist

JULY 29, 2022

Feel free to use my own health timeline as a guideline to document your health journey. 2009 Oct-Nov;25(9-10):577-81. 2009 Oct;16(5):385-91. As you add your symptoms to a health history timeline, reflect on what season it was when your allergy or thyroid symptoms worsened. 2010;20(7):755-761. doi:10.1089/thy.2010.1636.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The draft guidance, released on March 5, is open for comments until May 7, after which it will replace an earlier 2009 guidance for the industry.

FDA 52

FDA Documentation Communication 52

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.

Documentation 97

Documentation FDA Hospitals Dosage 97

ISPE

JULY 6, 2023

addresses the risk-based decision-making process as a consequence of the previously defined level of formality, alongside the levels of effort and documentation. Published August 2009. Risk-Based Decision-Making ICH Q9(R1) Section 5.2 Challenges 11, no. 1 (January 2020):1.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

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. 2009-0041.

Documentation 98

Documentation Dosage FDA Communication 98

The Thyroid Pharmacist

NOVEMBER 8, 2024

After being diagnosed with Hashimoto’s in 2009, I spent a lot of time, money, and resources on trying to figure out my root cause. I eventually did uncover and resolve multiple triggers, and was able to get into remission.

Immunization 72

Immunization Adverse Reactions Hospitals Vaccines 72