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Searching Content by Laura Koman ordered by Published Date Descending.
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1
Artificial Intelligence And Health Care—Key Regulatory Considerations For U.S. Operations
Artificial intelligence is being used in innovative ways in the health care industry to drive down costs and improve clinical outcomes.
United States
1 Feb 2018
2
Texas Legislature Approves Bill Reducing Barriers For Telemedicine
The Texas legislature passed S.B. 1107 yesterday, May 18, 2017.
United States
24 May 2017
3
EMA Consultation On The Revised Policy On Access To Documents
The EMA has launched a public consultation on the proposed revision to its policy on access to documents.
European Union
18 Apr 2017
4
GCP Renovation ICH Reflection On "GCP Renovation"
The aim is to proceed with initiating needed renovation work as soon as practical, for example, within the next year.
United States
18 Apr 2017
5
Ten Years Of Conditional Marketing Authorizations
CMAs allow pharmaceutical companies in the European Union to obtain the authorization to place a medicinal product on the market provided they subsequently fulfill certain conditions.
European Union
18 Apr 2017
6
President Trump Proposes Dr. Scott Gottlieb As FDA Commissioner
According to a White House statement, President Trump intends to nominate Scott Gottlieb, M.D., as FDA Commissioner.
United States
13 Apr 2017
7
Cures Corner: FDA Launches Regenerative Medicine Advanced Therapy Designation Program
In late January 2017, FDA took the first steps to implement certain provisions of the 21st Century Cures Act, signed into law on December 13, 2016, by launching a new designation program for regenerative medicine therapies.
United States
13 Apr 2017
8
FDA Delays Effective Date Of Amended Regulations Affecting "Intended Use" Definition
One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" would have taken effect, ...
United States
13 Apr 2017
9
The Continuing Story Of Manufacturers' Off-Label Promotion Of Approved Or Cleared Medical Products
Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products.
United States
13 Apr 2017
10
EC Invites Industry To Develop Self-Regulatory Rules For The Labeling Of Alcoholic Beverages
On March 13, 2017, the EC adopted a report concerning the mandatory labeling of the list of ingredients and the nutrition declaration for all alcoholic beverages.
European Union
23 Mar 2017
11
European Parliament Resolves To Promote Natural Alternatives To Pesticides
On February 15, 2017, the Members of the European Parliament adopted a resolution calling on the EC to draw up proposals to fast-track the evaluation, authorization, and registration of low-risk pesticides.
European Union
23 Mar 2017
12
FNS Extends Comment Period On Requirements For Processing Of Donated Foods
In the February 27, 2017, Federal Register, USDA's Food and Nutrition Service extended the comment period on a proposed rule to revise and clarify the requirements for the processing of donated foods.
United States
23 Mar 2017
13
FSIS Extends Comment Period For The Revision Of The Nutrition Facts Labels For Meat And Poultry
In the February 22, 2017, Federal Register, USDA's Food Safety and Inspection Service ("FSIS") extended the comment period for a proposed rule to amend the nutrition labeling requirements...
United States
23 Mar 2017
14
AMS Extends Comment Period For Several Rules
AMS also extended the comment period for an interim rule on amendments to the inspection requirements for fresh and processed fruits, vegetables, and other products to add an option for...
United States
23 Mar 2017
15
APHIS Delays Effective Date Of Select Agent And Toxin Regulations
In the February 16, 2017, Federal Register, USDA's APHIS delayed the effective date of a final rule amending the select agent and toxin regulations...
United States
22 Mar 2017
16
APHIS Extends Comment Period On GMO Regulations And Plant Pest Regulations
The proposed rule would also revise regulations regarding soil movement.
Worldwide
22 Mar 2017
17
FDA Reopens Comment Period For Notice On Food Color Additive Regulations
The draft guidance, when finalized, will assist manufacturers in determining whether a color additive derived from a plant material meets the specifications under certain FDA color additive regulations.
Worldwide
22 Mar 2017
18
Eastern European Leaders To Address "Double Standards" For Food
The leaders of the Visegrád Group plan to adopt a joint declaration summing up the process of integration.
European Union
22 Mar 2017
19
EFSA Issues Draft Guidance On Substances In Food For Infants Below 16 Weeks
All correctly submitted comments will be assessed and, if found to be relevant, taken into consideration by the Scientific Committee in finalizing the guidance.
Worldwide
22 Mar 2017
20
EFSA Proposes Simpler Food Safety Rules For Small Retailers
Following a request by the EC, theEFSA has developed a simplified approach to food safety management in small food retail businesses, such as grocery shops, butchers, and bakeries.
European Union
21 Mar 2017
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