The White House shelved a step-by-step guide prepared by U.S. health officials to help states safely reopen mass transit and businesses closed by the coronavirus pandemic, an administration official said on Thursday. This report produced by Chris Dignam.

The White House shelved a step-by-step guide prepared by U.S. health officials to help states safely reopen mass transit and businesses closed by the coronavirus pandemic, an administration official said on Thursday. This report produced by Chris Dignam.

The White House shelved a step-by-step guide prepared by U.S. health officials to help states safely reopen mass transit and businesses closed by the coronavirus pandemic, an administration official said on Thursday. This report produced by Chris Dignam.

Two new graphics from Diabetes UK's COVID-19 task force address inpatient use of subcutaneous insulin for managing hyperglycemia and ketoacidosis when intravenous equipment is unavailable.

In response to the growing interest in the availability of data associated with articles, PMC is reviewing current practices around data and seeking feedback on how to best serve the data needs of the research community.

As part of these efforts, the PMC policy statement on supplementary data was recently updated to more clearly articulate the requirement that any supplementary data (images, tables, video, or other documents / files) that are associated with an article must be deposited in PMC with an article. The search filter "has suppdata[filter]" can be used in PMC to discover records with associated supplementary data files.

In addition to providing supplementary data with an article, NLM is also encouraging journals and authors to make research data available in a public repository and include the relevant data citation(s) in the paper. Guidance for PMC data providers on tagging data citations is available in the Tagging Guidelines. This guidance is based on the JATS4R recommendations on data citations.

Starting this month, the NIH Manuscript Submission (NIHMS) system will also accept deposits of small datasets accompanying deposits of funded author manuscripts for inclusion of PMC. (Guidance for authors is available in the NIHMS FAQ.)

If you have suggestions on future directions in data for PMC to consider, please let us know at pubmedcentral@ncbi.nlm.nih.gov.

Peer review documents, including review reports and editor decision letters, are increasingly being published along with the articles they review. This practice is intended to make the publishing process more transparent. To support these efforts, PMC’s Tagging Guidelines have been updated to include the tagging of peer review documents. NLM encourages PMC-participating publishers, journals, and data providers to review this guidance. Please contact us at pubmedcentral@ncbi.nlm.nih.gov if you have any questions.

The 2018 World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Score was developed to establish a simple, standardized scoring system for researchers to quantify adherence to the 2018 WCRF/AICR Cancer Prevention Recommendations and assess its impact on cancer risk and other health-related outcomes. The aim of this commentary is to clarify potential points of ambiguity in its application, focusing on aspects related to specific subscore components (physical activity, fast foods, alcohol, and sugar-sweetened drinks), how to address different data needs due to varied data collection instruments, and future exploratory score approaches. Overall, we encourage researchers to utilize the standardized score to enhance comparability across populations and countries. Researchers who may adapt or augment the 2018 WCRF/AICR Score are strongly encouraged to provide detailed descriptions of their methods to promote transparency and reproducibility.

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Donald Trump has announced that the federal government will not be extending its coronavirus social distancing guidelines after they expire on Thursday.

As New Brunswick and other provincial governments contemplate launching COVID-19 contact-tracing apps, privacy watchdogs from across the country have issued joint guidelines on what they are describing as an "extraordinary" measure, urging transparency and accountability.

US drugmaker Alexion Pharmaceuticals fared better in its revenue and adjusted earnings figures in the…

The Department of Justice’s Civil Rights Division and the Department of Health and Human Services’ Office for Civil Rights today issued new technical assistance guidance for medical providers which will help people with mobility disabilities obtain accessible medical care.

The Justice Department today issued a letter to chief justices and administrators of state courts clarifying the obligation of courts that receive federal financial assistance to provide oral interpretation, written translation and other language services to people who are limited English proficient.

Today, the Departments of Justice and Education released two new guidance documents ¨C one for school districts and one for colleges and universities ¨C detailing the flexibility that the Supreme Court has provided to educational institutions to promote diversity and, in the case of elementary and secondary schools, reduce racial isolation among students within the confines of the law.

The Justice Department released two technical assistance documents today regarding the application of the Americans with Disabilities Act (ADA) to swimming pools. The documents can be found at www.ada.gov//qa_existingpools_titleIII.htm and www.ada.gov/pools_2010.htm.

New guidance released today by the U.S. Department of Housing and Urban Development (HUD) and the U.S. Department of Justice reinforces the Fair Housing Act requirement that multifamily housing be designed and constructed so as to be accessible to persons with disabilities.

Today, the U.S. Departments of Justice and Education released new guidance that provides colleges and universities with information about the ruling in Fisher v. University of Texas-Austin, and reiterates the Departments’ position on the voluntary use of race to achieve diversity in higher education.

The Department of Justice (DOJ), in collaboration with the Department of Education (ED), today released a school discipline guidance package that will assist states, districts and schools in developing practices and strategies to enhance school climate, and ensure those policies and practices comply with federal law.

"Too often, so-called “zero-tolerance” policies – however well-intentioned – make students feel unwelcome in their own schools. They disrupt the learning process. And they can have significant and lasting negative effects on the long-term well-being of our young people – increasing their likelihood of future contact with juvenile and criminal justice systems," said Attorney General Holder.

Attorney General Eric Holder and Secretary Arne Duncan today announced updated guidance to assist public elementary and secondary schools to ensure enrollment processes are consistent with the law and fulfill their obligation to provide all children – no matter their background – equal access to an education.

Especially as we approach the 60th anniversary of the Supreme Court’s decision in Brown v. Board of Education, in which Chief Justice Earl Warren called education “a right which must be made available to all on equal terms,” it is imperative that we do everything in our power to end policies or practices that deny this right to those who are constitutionally entitled to it.

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance 30 Dec 2019 Submission of Plans for Cigarette Packages …

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From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading →

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 

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion...… Continue Reading

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

By Rachael E. Hunt —

Company says Covid-19 pandemic will affect results from second quarter of 2020.

Trade groups representing the country's biggest consumer companies, including PepsiCo, Procter & Gamble and Clorox, wrote a letter to Vice President Mike Pence on Thursday urging federal guidance on how to safely manage their factory workers as states begin to reopen for business.

A growing number of companies has nixed earnings guidance amid the coronavirus pandemic, and some in the corporate world say they should be dropped permanently.

Apple did not issue guidance for the quarter ending in June, as it usually does. The company withdrew guidance for its second-quarter in February as the Covid-19 coronavirus spread in China.

A number of European airlines have dropped their financial guidance for the year, as the ongoing coronavirus pandemic creates widespread uncertainty about when business will return to normal.

Jeff Lawson, Twilio CEO, joins 'Closing Bell' to discuss the surge in demand for the product amid Covid-19, earnings, and the company's assistance to telehealth initatives.

Is Abbott Labs a buy? With CNBC's Melissa Lee and the Fast Money traders, Guy Adami, Tim Seymour, Pete Najarian and Steve Grasso.

One of the major issues faced by the voters of the Mumbai North West constituency was that most of their names were missing from the voters' list, and they did not get much guidance at the polling booths. Those who did not find their names on the list, had to return without casting their votes, and they even complained that the officials posted at the polling stations could not address their queries.

The fight in the constituency is between sitting MP and Shiv Sena – BJP candidate Gajanan Kirtikar and Congress NCP candidate Sanjay Nirupam. Due to the scorching summer heat, most people preferred to vote in the early morning and evening hours. Long queues were spotted outside polling stations at Jogeshwari East, Goreagaon, Dindoshi, Andheri East and Versova.

The Pathak family whose names were missing from the list

Missing names

A family of three — senior citizen Parashar Pathak, his wife Anju Pathak and daughter Silky Pathak had landed at the Gyan Kendra School in Andheri West early to cast their votes, however they were shocked to find their names missing from the list. Speaking to mid-day, Silky said, "My mother had a doctor's appointment, so we decided to first cast our votes and then head to the clinic. But we were shocked to see that our names were missing. The officials at the polling station could not help us in any way, and after wasting two hours we left."

Shilpa Ajgaonkar from Goregaon East, who faced the same problem, said, "Though my husband's name was there on the voters' list, my name was missing. I had no option but to return after two hours without voting because even the polling officials could not help." Forty-six-year-old Genevieve Da Silva said that the election officials at the entrance of the St Anthony High School told her that her name was not there on the electoral roll. However, her husband, Clinton, could vote.

Goregaon East resident Shilpa Ajgaonkar's name was missing from the list

Senior citizens enthusiastic

Even though senior citizens of the North West constituency showed a lot of enthusiasm this time, many of them said that the facilities at the polling centres could have been better. A residents' association in Juhu had arranged for a pick-up and drop facility for senior citizens and even wheelchairs were available at polling stations.

Speaking to mid-day, Juhu resident Shankar Adnani, 82, said, "We are happy that adequate arrangements had been made for senior citizens at our centre and we did not face any difficulty in reaching the polling booth." However a youngster, who voted at the Gyan Kendra School polling station in Andheri West, said, "At the Gyan Kendra school, ramps for senior citizens were kept only at one place. Some of them, who had to vote at the adjacent building, were made to sit on chairs, which were then carried to the booth."

First-time voter Devangshi Haria from Four Bungalows

No ink applied

Meanwhile, first-time voter Muskan Gupta, who cast her vote at the Gyan Kendra School, said that an official at the booth forgot to mark her finger with ink. "I have cast my vote but the official in-charge might have forgotten to ink my finger. Even I was not aware of the exact process."

First-time voters
Four Bungalows resident and a first-time voter Devangshi Haria said, "I always wanted to vote and I am happy that I could do it this time. More youngsters should come out and vote because this is the process of nation building." Versova resident Mahesh Babaji Padyal, who is also a first-time voter, said, "I have been waiting to cast my first vote since over a year now and finally I could do it. I feel happy that my vote will play an important role in deciding the fate of the candidate, who will represent us in the Lok Sabha."

First-time voter Mahesh Babaji Padyal from Versova

Kurla resident Rita Vishwakarma was a happy mother on Monday since both her children — 19-year-old son Chandraprakash Vishwakarma and 22-year-old daughter Komal Vishwakarma — voted for the first time. As no one had explained them the voting process, the brother-sister duo said they figured it out themselves.

Muskan Gupta, whose finger was not inked

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The Luxembourg direct tax administration has published a circular including comprehensive guidance for the recently introduced changes to the special tax regime for intellectual property income.

Singapore's tax agency has made two announcements recently concerning the automatic exchange of information on foreign taxpayers' affairs, on the Common Reporting Standard and the US Foreign Account Tax Compliance Act.

The Inland Revenue Authority of Singapore on February 23, 2018, released the fifth edition of its Transfer Pricing Guidelines for income tax.

The Inland Revenue Authority of Singapore has released new transfer pricing guidance on determining the economic value of taxpayers' commodity marketing and trading activities in Singapore.

The Inland Revenue Authority of Singapore has updated its guidance on the introduction from January 1, 2020, of an obligation on Singaporean taxpayers to collect GST on imported services under a reverse charge.

The Malaysian tax agency on December 1 released guidance on whether gifts provided for no consideration can be excluded from the goods and services tax net.

Malaysia's tax agency has released Public Ruling No. 1/2018, setting out the goods and services tax rules concerning the sale of buildings on commercial land that are used for both residential and commercial purposes.