Recent News and Industry Developments

FDA Announces Exclusion of Three Substances from its Section 503B Bulk List
Advisories | News | FDA Announces Exclusion of Three Substances from its Section 503B Bulk List

November 5, 2018 Drug compounding is the process of combining (two or more drugs), mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.[1]… Read more »

PROTECT INITIATIVE: ADVANCING CHILDREN’S MEDICATION SAFETY
Events | News | PROTECT INITIATIVE: ADVANCING CHILDREN’S MEDICATION SAFETY

Elizabeth Whalley Buono will be presenting “Federal and State Responses to the Opioid Epidemic” at the Center for Disease Control’s (CDC) Annual meeting of The Prevention of Overdoses and Treatment… Read more »

FDA APPROVES FINAL OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY WITH A FOCUS ON EDUCATION OF BOTH PROVIDERS AND PATIENTS
Advisories | News | FDA APPROVES FINAL OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY WITH A FOCUS ON EDUCATION OF BOTH PROVIDERS AND PATIENTS

October 25, 2018 This past week, as part of the U.S. Food and Drug Administration’s (FDA) goal of reducing serious adverse outcomes resulting from inappropriate prescribing and misuse and abuse… Read more »

LEADING HEALTH LAW FIRM HANCOCK DANIEL HOSTS PHARMACY COMPOUNDING SYMPOSIUM
Events | News | LEADING HEALTH LAW FIRM HANCOCK DANIEL HOSTS PHARMACY COMPOUNDING SYMPOSIUM

Hancock Daniel joins VCU and Virginia Bio for an Inaugural Pharmacy Compounding Symposium in November Richmond, VA, October 19, 2018– This Inaugural Pharmacy Compounding Symposium will be held on Friday,… Read more »

ANNUAL FDA INTER-GOVERNMENTAL WORKING MEETING REVIEWS REGULATORY PROGRESS AND ANNOUNCES NEW GUIDANCE FOR COMPOUNDING INDUSTRY
Advisories | News | ANNUAL FDA INTER-GOVERNMENTAL WORKING MEETING REVIEWS REGULATORY PROGRESS AND ANNOUNCES NEW GUIDANCE FOR COMPOUNDING INDUSTRY

October 2, 2018 On Sept. 24, 2018, the U.S. Food and Drug Administration (FDA) convened its seventh inter-governmental working meeting as part of its commitment to maintaining close communication with… Read more »

IMPORTANT REVISIONS REGARDING CREDENTIALING REIMBURSEMENT
Advisories | News | IMPORTANT REVISIONS REGARDING CREDENTIALING REIMBURSEMENT

9/25/2018 Credentialing physicians is frequently an arduous process that takes several months to complete and involves hours of paperwork detailing every certification, academic experience and personal background. Thankfully, for Virginia… Read more »

OPIOID BILLS WILL LIKELY RESULT IN SIGNIFICANT CHANGES IN THE WAY OPIOIDS ARE PRESCRIBED, DISPENSED AND PACKAGED
Advisories | News | OPIOID BILLS WILL LIKELY RESULT IN SIGNIFICANT CHANGES IN THE WAY OPIOIDS ARE PRESCRIBED, DISPENSED AND PACKAGED

September 21, 2018 On Monday September 17, 2018, with almost unanimous support, the Senate passed a package of 70 bills that collectively seek to address the myriad of challenges posed… Read more »

Virginia Impact Investing Forum and Social Entrepreneurship
Events | News | Virginia Impact Investing Forum and Social Entrepreneurship

Elizabeth Whalley Buono will be presenting Scaling the Health Economy at the “Virginia Impact Summit” hosted by the Office of Governor Northam, the Virginia Impact Investing Forum & Social Entrepreneurship… Read more »

What’s Happening in the Medicare Advantage World
Advisories | News | What’s Happening in the Medicare Advantage World

August 23, 2018 The Medicare Advantage sector is experiencing steady growth. From the increasing number of enrolled beneficiaries, to health insurers investing in this privatized version of traditional Medicare, to… Read more »

MALPRACTICE POINTERS WHEN PRESCRIBING DRUGS FOR OFF-LABEL USES
Advisories | News | MALPRACTICE POINTERS WHEN PRESCRIBING DRUGS FOR OFF-LABEL USES

August 21, 2018 Unlike the regulatory prohibitions against drug and device manufacturers advertising and/or promoting use of their products off-label, doctors are free to responsibly use FDA-regulated products outside of… Read more »

New OIG Report Highlights Risk of Fraud and Abuse at Compounding Pharmacies and Recommends the Launch of Further Investigations
Advisories | News | New OIG Report Highlights Risk of Fraud and Abuse at Compounding Pharmacies and Recommends the Launch of Further Investigations

August 13, 2018 The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released a new report  this month highlighting its concern with the enormous increase… Read more »

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