PhillyCooke Consulting has added new services from the humble start more than five years ago, when I used to joke that the company included both me and my laptop.

In addition to continuing to provide regulatory consulting services, PhillyCooke Consulting now offers:

• Submission Preparation Services for Ad Agencies
• Medical Editing
• Proofreading, and 
• Medical Writing. 

The Digital Health Coalition asked for my views on the renewed emphasis on privacy for pharmaceutical marketers. I shared a few thoughts here.

It was just confirmed that I'll be teaching in Temple University's RA/QA MS program this spring. Specifically, I'll be teaching the ad-promo course.

If you or anyone you know is interested, please reach out to me for information. The course will be taught out of the Fort Washington campus, but online enrollment is permitted.

Here's the complete schedule of classes for the spring.

UPDATE: The guidance mentioned below was released. Here's the link.

The FDA has released the CDER Guidance Agenda. For ad-promo professionals, the most most significant item is the inclusion of an item labeled:

• Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers 

I live in Pennsylvania, just outside Philadelphia, in Montgomery County. Currently, Montco is the worst hit county in Pennsylvania for the COVID-19 outbreak. Consequently, the governor ordered all non-essential businesses to close more than a week ago in Montco, and yesterday expanded that order statewide.

Because most of my work is from home, the outbreak has not yet affected my ability to provide client service; however, for the foreseeable future all live speaking engagements are cancelled.

I was scheduled to deliver the device workshop at DIA advertising conference last week and also had some workshops scheduled with FDAnews for May and June. DIA's conference was been delayed with a decision about how to proceed still to be determined. I'll post an update here when I know more.

The May FDAnews workshop has been cancelled, and the June workshop is on hold. When I know more, I'll post an update.

In addition, I am part of the leadership committee for the Philadelphia RAPS chapter. We held our last event on March 5 at Temple University, and the next day, RAPS HQ sent out a notice asking chapters to hold off on live meetings for March and April. Currently, the chapter leadership is discussing other options, such as webinars to continue getting information to our membership during the outbreak.

While we adjust to life during a pandemic, I'll provide updates as I can. Stay safe and wash your hands!

The COVID-19 pandemic has brought to the fore some issues of ad-promo for FDA-regulated products. I'm posting here to highlight some developments and correct some of the discussion.

Snake Oil & Enforcement

Off-Label Promotion & Outbreaks

Yokogawa Electric Corporation (Yokogawa) hereby notifies that on this date it has transferred all shares of Yokogawa Medical Solutions Corporation, a consolidated subsidiary, to Fujifilm Corporation (Fujifilm).

Yokogawa Electric Corporation announces that it has received the IR Special Award from the Japan Investor Relations Association (JIRA). This is the first time that the company has received an IR Award from JIRA.

Yokogawa Electric Corporation (TOKYO: 6841) announces that its control system development organization has obtained ISASecure Security Development Lifecycle Assurance (SDLA) certification from the ISA Security Compliance Institute (ISCI) .

In March 2019, Yokogawa completed a demonstration project for the Optimization of the Operation Control of Oil Refining Plants in Indonesia. The New Energy and Industrial Technology Development Organization (NEDO) awarded this project to Yokogawa in 2013.

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has made it onto CDP's Water Security A List and Supplier Engagement Leader Board. The A listing is for the company's sustainable water management practices and disclosure of information on these activities, and the selection to the leader board is for the company's leadership in engaging with its suppliers around the world to reduce carbon emissions and combat global warming.

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has acquired capital in APB Corporation (APB), a pioneer in the development of a next-generation lithium-ion battery called the “All Polymer Battery,” with the aim of growing Yokogawa’s energy management system (EMS) business. The two companies have agreed that Yokogawa will provide energy management technology needed for the efficient operation and optimization of large-scale storage batteries.

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has developed the SU10 Single Cellome Unit, a device that uses a nanopipette to inject substances such as genes and drugs and aspirate intracellular materials at target locations in individual cells.

Yokogawa Electric Corporation (TOKYO: 6841) announces that on March 20, 2020, it completed the acquisition of all shares in Denmark-based Grazper Technologies ApS (Grazper), as mutually agreed. Grazper has developed advanced artificial intelligence (AI) technologies for analyzing images, and Yokogawa aims to leverage these technologies within its various existing businesses and to develop new industrial AI solutions.

Yokogawa Electric Corporation (TOKYO: 6841) announces that its subsidiary Yokogawa Turkey Industrial Automation Solutions A.S. (Yokogawa Turkey) has won an order to provide a control system and field instruments for the Zerger gas-fired power plant in Turkmenistan. The order was received from Renaissance Heavy Industries, a major construction company in Turkey that is involved in the construction of this plant for Turkmenenergo, a state-owned power utility in Turkmenistan. This is Yokogawa's first control systems order for a power plant in this country.

On March 25, 2020, Hitachi Capital Corporation, Yokogawa Electric Corporation (TOKYO: 6841), and amnimo Inc., a subsidiary of Yokogawa, entered into a comprehensive partnership agreement with an aim to provide new services by adding Industrial IoT ("IIoT") to each company's technologies, know-how, and lease equipment.

Yokogawa Electric Corporation (TOKYO: 6841) announces that Yokogawa Solution Service Corporation, a wholly owned subsidiary, has installed a Yokogawa control system for one of Japan's largest wind-power plants, and that this facility, Wind Farm Tsugaru, has come online. This plant was built by Green Power Tsugaru GK, a limited liability company that belongs to Green Power Investment Corporation.

Yokogawa Electric Corporation (TOKYO: 6841) announces the release of artificial intelligence (AI)-enabled versions of the GX series panel-mount type paperless recorders, GP series portable paperless recorders, and GA10 data logging software, which are components of the highly operable and expandable SMARTDAC+data acquisition and control system. This new AI functionality includes the future pen, a function developed by Yokogawa that enables the drawing of predicted waveforms. Yokogawa is also releasing a new CPU module for the e-RT3 Plus edge computing platform that is environmentally robust and Python compatible. The GX/GP and e-RT3 release is set for April 8, and the GA10 software will be released on May 13. The SMARTDAC+ system is a product in the OpreX Data Acquisition family, and the e-RT3 Plus is part of the OpreX Control Devices family.

Yokogawa Electric Corporation (TOKYO: 6841) announces that on April 8, it completed the acquisition of all shares of Fluid Imaging Technologies, Inc., as mutually agreed.

Yokogawa Electric Corporation announces that Dr. Penny Chen of Yokogawa Corporation of America has been selected by Control, a prestigious and influential industry publication in the US, to be inducted into its Process Automation Hall of Fame, Class of 2020. Dr. Chen is senior principal technology strategist at Yokogawa Corporation of America's U.S. Technology Center based in Dallas, Texas.

The UK is planning to bring in compulsory 14-day quarantine for all travellers arriving in the country from any part of the world, except the Republic of Ireland, as part of measures to track the spread of coronavirus.

As Mumbai continued to lead the charts in Covid-19 cases and resultant deaths, the city’s civic chief was on Friday summarily shunted out and replaced by a junior with no experience of heading any of the state’s top five municipal corporations.

"We institutionalised WFH guidelines even before the commencement of the lockdown," said Ranjan Kumar Mohapatra, director (HR), Indian Oil.

Over 1 lakh migrant workers from Uttar Pradesh stranded in different parts of the country following the coronavirus-induced lockdown will return to the state by Saturday night on 114 trains, a senior government official said.

In a letter to Putin Modi pledged India’s support to Russia on the occasion and hailed Russian soldiers who laid down their lives during WW II to defeat Fascism and Nazism.

The ruling JD(U) on Saturday slammed AAP for claiming that it bore the cost of ferrying migrant workers from Delhi to their home in Bihar, saying the party was speaking "half-truth" as the Arvind Kejriwal government has sought reimbursement of the payment.

During the high-level meeting with Arunachal Pradesh, Assam, Manipur, Meghalaya, Mizoram, Nagaland, Tripura and Sikkim, Vardhan appreciated the dedication of all the states in combating COVID-19.

Elsewhere, Belarus, which has not locked down despite increasing case numbers, saw tens of thousands of people turn out to mark Victory Day, the anniversary of Nazi Germany's defeat in 1945.

While nearly eight lakh migrant workers stranded in Haryana have registered themselves on a government portal to return to their native states, over 1.5 lakh of them have applied on the same portal from different states to return back to work, state Home Minister Anil Vij said.

Delhi Congress wrote to the chief minister and the Delhi government's chief secretary as well, expressing its readiness to pay for the train fares of the migrants, said the Delhi Congress president. Delhi government in last few days arranged train travel of 1,200 migrant workers from Bihar and over 1,000 from MP, who were sheltered at government facilities.

The Ahmedabad Municipal Corporation (AMC) Commissioner Vijay Nehra was already pushed into a quarantine following the rising numbers of patients in the city and Additional Chief Secretary Rajiv Gupta was brought in as in charge of the fight against Covid in Ahmedabad while CEO of Gujarat Maritime Board Mukesh Kumar was brought in as the incharge Commissioner.

French commentators initially praised the ability of China’s regime to impose lockdown to fight Covid. But the French mood changed in late March, says Marc Julienne, China researcher at the French Institute for International Relations (IFRI).

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