Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

pharmaphorum

OCTOBER 1, 2021

The debut – raising upwards of £350 million from new shares – is the largest IPO for a UK biotech company since allergy drug specialist Circassia in 2014. It may also use the cash injection for “in-licensing opportunities and potential acquisitions”, according to the document.

Documentation 52

Documentation Vaccines 52

Syner-G

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).

Documentation 40

Documentation Packaging Labelling 40

pharmaphorum

DECEMBER 29, 2022

The case revolves around allegations that Novartis made an agreement in 2011 with Par Pharmaceutical when Exforge (valsartan/amlodipine) was nearing the end of its patent life that was designed to keep Par’s generic version of the drug off the market until 30 September, 2014.

Specialty Pharmacies 52

Specialty Pharmacies Documentation 52

Pharmaceutical Technology

MARCH 30, 2023

Broadening uses and secured full approvals Since its first approval in September 2014, Keytruda has achieved blockbuster status on the market. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials.

Chemotherapy 52

Chemotherapy Packaging Documentation 52

Syner-G

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

Documentation 52

Documentation Drug Development Communication 52

The Digital Apothecary

MAY 11, 2018

My Years as an Assitant Professor Luckily (sarcasm) part of going up for promotion includes creating a document a couple hundred of pages long detailing what you did. So a lot of the past few years are fresh in my mind and by annual activity, reports are useful just to document my experiences.

Hospitals 130

Hospitals Documentation 130

Pharmaceutical Technology

OCTOBER 5, 2022

Between 2009 and 2014, the time period of Biogen’s alleged misconduct, the standard of care for MS involved the use of Biogen’s immunomodulatory drugs such as Avonex (Interferon beta-1a), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab).

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies 59

Pharmacy Joe

OCTOBER 25, 2023

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage 52

Dosage Inpatient Packaging Documentation 52

pharmaphorum

JANUARY 13, 2023

A daily 20 mg does of atorvastatin – available as a low-cost generic – is the statin of choice for primary prevention, according to the document. It is the second time that NICE has lowered the threshold for statin prescribing, after cutting it from 20% to 10% in 2014.

Documentation 52

Documentation 52

RX Note

JUNE 5, 2023

Change gloves every 30 minutes during compounding or immediately when damaged or contaminated, unless otherwise recommended by the manufacturer's documentation. Double gloving requires 1 glove to be worn under the cuff of the gown and the second glove over the cuff.

Compounding 52

Compounding Packaging Hospitals Chemotherapy 52

Eye on FDA

JULY 7, 2020

The agency had never said that this was not a permitted practice and only made it clear by issuing the letters, rather than having enunciated the parameter through a guidance document about digital communications. One of them was about the appropriate use of links. FDA said they would produce a guidance by the end of 2010, but did not.

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

ID Stewardship

APRIL 13, 2023

BCPS, BCIDP Article Posted 14 April 2023 In 2014 CDC released the Core Elements of Hospital Antibiotic Stewardship Programs (Core Elements) to help hospitals increase infection cure rates while reducing treatment failures, C. Gauthier, Pharm.D., ” Given that we cannot be everywhere all the time, how can this be demonstrated?

Hospitals 98

Hospitals Inpatient Documentation Communication 98

pharmaphorum

FEBRUARY 9, 2021

It makes for an agreement which is neither a legal document nor a policy one. 192 companies were members of the VPAS in 2019 versus 175 in the previous deal, the 2014 Pharmaceutical Price Regulation Scheme (PPRS). In the old days of the PPRS there were annual reports to Parliament (the last one found dates from 2014 ).

Documentation 67

Documentation 67

RX Note

MARCH 14, 2023

Document the antimicrobial therapy in the patient's medical record or medication chart, including the indication and the intended duration of therapy before further review or cessation. Example of patients with altered pharmacokinetics (e.g.

Medical Records 52

Medical Records Hospitals Documentation 52

FDA Law Blog: Biosimilars

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

Documentation 59

Documentation Vaccines Drug Development 59

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?

Biosimilars 98

Biosimilars Labelling Documentation 98

ID Stewardship

DECEMBER 13, 2024

It may be derived from work completed inthe microbiology lab, unitsdispensed from the pharmacy, administrations performed by nurses, expenditures produced from drug purchases, documentation within any area of the electronic medical record, extraction from supplemental tools or data warehouses, and so much more.

Communication 52

Communication Medical Records Inpatient Documentation 52

Pharmaceutical Technology

SEPTEMBER 26, 2022

Given the conflict present in the eastern part of Ukraine from 2014, sponsors, investigators and logistics providers were prepared for potential disruption. CROs and sponsors use remote source document verification, as approved by the regulator pre-war. Using technology and decentralisation has also contributed.

Packaging 52

Packaging Documentation 52

European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Available from: [link] q=US10821210B2. cited 2023July].

Vaccines 111

Vaccines Communication Immunity Immunization 111

Pulses

SEPTEMBER 26, 2023

2 The Pharmacist’s Patient Care Process, introduced in 2014, highlights the importance of using patient-centered treatment options to optimize health and medication outcomes. Within PharmCas, applicants have the option to document a maximum of eight previous employments.

Communication 59

Communication Hospitals Documentation 59

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

According to documents in the PTO’s Patent Center, Lilly has not yet filed a response. RE 44,599 and RE 44,638 were submitted nearly ten years ago (a point not lost on Gilead as noted below), on September 17, 2014 (Docket Nos. Our second example follows the same pattern as the first example above.

Documentation 59

Documentation 59

Syner-G

AUGUST 9, 2022

Hosted software to publish regulatory submissions in the electronic common technical document (eCTD) format was deployed. By early 2014, the Regulatory Operations group was fully operational and ready to offer electronic publishing services to IMPACT’s clients. The staff to manage and support this group was secured.

Packaging 40

Packaging Documentation 40

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

The Thyroid Pharmacist

JULY 14, 2023

10] I initially wrote a guide on LLLT for my clients in my Hashimoto’s Self-Management Program in 2014, before the follow-up study was done, and was concerned that the effects wouldn’t last. Remission of Hashimoto’s thyroiditis in a twelve-year-old girl with thyroid changes documented by ultrasonography. 2010;20(10):1187-1190.

Dosage 98

Dosage Immunization Immunity Documentation 98

STAT

FEBRUARY 9, 2024

Surgeon General Luther Terry’s landmark Report, “ Smoking and Health ,” which definitively documented the causal link between smoking, disease, and death. Tobacco control policies implemented between 1964 and 2014  saved  8 million lives in the United States. In

Documentation 352

Documentation 352

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

OHT-7’s well documented meltdown during the COVID-19 public health emergency should serve as an object lesson. 2, 2014), [link]. [12] Even if MDUFA VI were to allow the hiring of a significant number of new personnel, implementation of the Proposed Rule would begin before those employees arrive. 31, 2023), [link]. [10] 11] Jeffrey N.

Research Laboratories 69

Research Laboratories Documentation 69

Putting Patients First Blog

SEPTEMBER 9, 2024

amazonaws.com/s3fs-public/documents/Update_HHS_Disparities_Dept-FY2020.pdf Retrieved from https ://www.cms.gov/files/document/quality-motion-cms-national-quality- strategy.pdf 8 James, C., Leading causes of death in nonmetropolitan and metropolitan areas—United States, 1999–2014. The Lancet , 389(10077), 1453-1463. Auerbach, J.,

Insurance Coverage and Processing 40

Insurance Coverage and Processing Hospitals Inpatient Documentation 40

Putting Patients First Blog

FEBRUARY 6, 2024

autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L., The economic contribution of university/nonprofit inventions in the United States: 1996-2015. Retrieved from https ://w ww. Graddy-Reed, A., and Feldman, M. Retrieved from https ://ww w.nc

Communication 40

Communication Documentation Drug Development 40

The Thyroid Pharmacist

MARCH 31, 2023

There are many well-documented side effects of antidepressants and benzodiazepines, ranging from the rare but serious – suicidal ideation/action, homicidal ideation/action, and even death – to the very common – brain fog , weight gain , sexual dysfunction , and feeling disconnected from reality Published 2017 Sep 26. doi:10.3389/fpsyg.2017.01668

Immunization 105

Immunization Immunity Dosage Documentation 105

Putting Patients First Blog

JULY 15, 2024

Increased transparency about data collection methods, including detailed metadata and documentation on how data is collected, processed, and any limitations, also plays a key role in facilitating access and use. Retrieved from https ://www.cms.gov/files/document/cmsmodernizinghealthcare.pdf 13 Zhang, S., 1, 2, and 3). Grenwelge, C.,

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Coverage and Processing Communication Documentation 52

Putting Patients First Blog

JANUARY 10, 2024

9,10,11 The current verification process poses substantial challenges for formerly incarcerated individuals, who often encounter difficulties in securing necessary documentation and employment. These resources should include guidelines on qualifying life events, necessary documentation, and deadlines. Retrieved from https ://w ww.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Diabetes 40

The Thyroid Pharmacist

JULY 29, 2022

Back in 2014, I found that my Hashimoto’s flared up after using a particular lip gloss; once tested, it came back as containing arsenic! . Feel free to use my own health timeline as a guideline to document your health journey. Published March 2014. 2014 Aug;7(8):813-823. Wildfire Emissions and Particulate Matter.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

pharmaphorum

JUNE 10, 2021

In the case of Eli Lilly, they reported that the list price of their Humalog (insulin) product rose from $391 to $594 from 2014 to 2018, yet the company’s net revenue (revenue after these PBM and other rebates are paid) per dose fell from $147 to $135 (per patient, per month) during the same period.

Drug Pricing 105

Drug Pricing Vaccines Pharmaceutical Companies Pharmaceutical Companies 105

European Pharmaceutical Review

JULY 13, 2023

5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events. 2014 Jan;32(1):40-51. British journal of pharmacology. 2005 Dec;146(7):913-5. Hay M, Thomas DW, Craighead JL, et al. Nature biotechnology.

Compounding 98

Compounding Drug Development Clinical Pharmacology Documentation 98

Putting Patients First Blog

SEPTEMBER 9, 2024

These codes facilitate proper documentation and reimbursement, ensuring that health care providers are fairly compensated for the critical services they offer. The NHC supports the increased utilization of Z-codes to document social risk factors as part of the PIN services. JAMA Network Open, 3(5) , e205105. 6 Singh, G. and Siapush, M.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Documentation Vaccines Communication 40

Putting Patients First Blog

OCTOBER 3, 2024

Since the International Consensus Framework was introduced in 2014, over a dozen similar national collaborations have emerged, aligning health stakeholders and driving the adoption of ethical business practices across entire health systems. Consensus Framework document here. health system. Read the U.S. Calloway, Dr. Omar A.

Documentation 40

Documentation Communication 40