Regulatory
117th Congress and Biden Administration Underway
By Pete Evich, AAHP Government Affairs On Jan. 20, Joe Biden was sworn in as the 46th President of the United States. On the same day, both of Georgia’s newly elected Democratic Senators were also sworn into the U.S. Senate. These events put the Democrats in control of both readm more…
Read More2020 Presidential & Congressional Elections: Outcome and Agenda Outlook in the 117th Congress
By Pete Evich, AAHP Regulatory Affairs Presidency and Congress President-elect Joe Biden managed to defeat an incumbent president — the first time that’s happened in 28 years. Sen. Kamala Harris made history as the first woman, first Black person, and first South Asian American person to be elected vice readm more…
Read MoreHow Real-World Data Is Impacting Health Care Decisions Today
By Mark Land, AAHP President I have been interested in the application of Real-World Data (RWD) and Real-World Evidence (RWE) for some time now. Originally, I confused RWD and RWE with Patient Centered Data (PCD). In doing so, I thought that patient-supplied evaluation, such as Quality of Life, Compliance, and readm more…
Read MoreHomeopathic Process Validation for Beginners
Consistent, effective, high-quality homeopathic products. That’s what our consumers want in each and every dose. Yet quality doesn’t happen by accident. Manufacturers must create it through process validation. Each manufacturer must ask themselves: Do I have scientific evidence that my (manufacturing) process is capable of reliably delivering quality product? readm more…
Read MoreCOVID-19 CARES Act Aids Availability of OTC Products
On March 27, President Trump signed into law the Coronavirus Aid Relief and Economic Security (CARES) Act (HR 748). This landmark legislation provides financial relief for workers, small businesses, and healthcare professionals affected by the coronavirus…
Read MoreHomeopathy Mentioned Twice in FDA 2021 Budget Is Telling of Issues to Come
By Mark Land, AAHP President | In February, the White House released the President’s Fiscal Year 2021 Budget. Correspondingly, each agency publishes a detailed budget justification…
Read MoreIn Times of Public Health Crisis, Vulnerable Consumers Look to Us for Sound Advice
By Mark Land, AAHP President | I have experienced many infectious disease crises thus far in my lifetime and each one was characterized by fear and uncertainty…
Read MoreAAHP 2019: Reawakening the Regulatory and Retail Dialog
By Mark Land, AAHP President This year marks the fifth year in a cycle of regulatory review of homeopathic drug product labeling, safety, and quality. AAHP has been there for the industry as an advocate and representative over the entire duration. In 2019 AAHP provided direction and regulatory thought-leadership within readm more…
Read MoreTrump Nominates New FDA Commissioner
Senate Hearing Set for Nov. 20 By Pete Evich, AAHP Govt. Relations On Nov. 1, President Trump nominated Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next U.S. Food and Drug Administration (FDA) commissioner. If confirmed by the Senate, a process readm more…
Read MoreWhy It’s Crucial to Monitor FDA Guidances
By Mark Land, AAHP President It can take several years for manufacturers to implement new guidelines from the Food and Drug Administration (FDA)—and that means they could be at risk in the meantime. However, manufacturers can “get ahead of the game” by monitoring FDA’s guidance development agenda. FDA’s authority to readm more…
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