Docket Number: FDA-2014-D-1461 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Office of the Commissioner, Office of Clinical Policy and Programs, Office of Orphan Products Development This guidance provides information on …
Docket Number: FDA-2018-D-1175 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for …
Docket Number: FDA-2018-D-4524 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The purpose of this document is to recommend international standards for, and promote harmonisation of, …
Docket Number: FDA-2019-D-0358 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research [Draft published 3/13/2019] This guidance is one in a series of guidances …
Docket Number: FDA-2018-D-1638 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The purpose of this guidance is to provide general recommendations on the development of antiretroviral ( …
Docket Number: FDA-2013-D-0814 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The purpose of this guidance is to provide recommendations to sponsors regarding the submission of an …
Docket Number: FDA-2019-D-4751 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Drug Evaluation and Research This guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs for which …
Docket Number: FDA-2000-D-0942 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The number of medicinal products currently labeled for pediatric use is limited. This guidance is …
Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This draft guidance provides recommendations on how to interpret the pediatric study requirements of the Pediatric Research Equity Act (Public Law 108-155) (PREA). PREA amends the …
Growing need for eco-friendly packaging and supply chain cost-effectiveness drives returnable packaging market growth. AUSTIN, TEXAS, USA, April 11, 2024 /EINPresswire.com/ -- 𝐌𝐚𝐫𝐤𝐞𝐭 𝐒𝐢𝐳𝐢𝐧𝐠: The Returnable Packaging Market as per the 𝐒𝐍𝐒 …
Issued by: Guidance Issuing Office Center for Drug Evaluation and Research U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) October 2012 Clinical Antimicrobial Guidance for …
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …
Docket Number: FDA-2018-D-1456 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations for the conduct of in vivo absorption trials for topically applied active ingredients that are under …
Burlingame, April 11, 2024 (GLOBE NEWSWIRE) -- CoherentMI published a report, titled, United States Distilled Spirits Market was valued at US$ 5.51 Billion in the year 2023, and is anticipated to reach a US$ 8.2 Billion by 2031, with growing at a CAGR of 5 …
SAN DIEGO, April 11, 2024 (GLOBE NEWSWIRE) -- Shareholder rights law firm Johnson Fistel, LLP is investigating potential violations of securities laws by Globe Life Inc. ("Globe Life" or "the Company") (NYSE: GL). We are looking into …
WAWA, Pa., April 11, 2024 (GLOBE NEWSWIRE) -- Today, Wawa proudly announced the date of its first official store opening in North Carolina and shared additional details on stores under construction in the state. Wawa’s first store in North Carolina will be …
ATLANTA, April 11, 2024 (GLOBE NEWSWIRE) -- Digital Element, the global IP geolocation and audience insights leader, today announced that it has been selected as the winner of the “Data Solution of the Year for Marketing” award in the 5th annual Data …
The Green Beauty Community Releases A Sustainable Salon & Professional Beauty Guidebook SAN DIEGO, CALIFORNIA, UNITED STATES, April 11, 2024 /EINPresswire.com/ -- The Green Beauty Community, a pioneering collective dedicated to transforming the …
With sponsorship of the German Customs Cooperation Fund (CCF/Germany), a WCO National Workshop on the Tariff Classification of Dairy Products, Food Supplements and Multi-functional High-tech Devices was held in the headquarters of the Customs …
With the financial support of the Japan Customs Cooperation fund, a mission recently took place in Hanoi, Vietnam under the umbrella of the WCO’s Revenue Package programme, designed to assist Customs administrations in the identification and collection of …
