Biden Administration Rescinds Trump Administration Insulin …
2021年10月26日 · One of the final healthcare actions made by the Trump Administration has been rescinded by the Biden Administration. On December 23, 2020, the Trump Administration finalized a rule that directed the Department of Health and Human Services (HHS) to take action to require that federally qualified health centers (FQHCs) make insulin and injectable epinephrine available to certain patients at 340B ...
FDA Releases Draft Guidance on Indications and ... - Policy
On July 9, 2018, the United States Food and Drug Administration (FDA) issued draft guidance entitled, “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format.”The guidance is intended to assist applicants in writing their Indications and Usage section of product labeling for new …
FDA Issues New Draft Guidance on Submitting Formal Meeting …
2018年3月6日 · A new draft guidance from FDA explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/ videoconference meetings or written responses only, what sponsors should include in that request, how FDA can respond, how long the agency can take to respond, and how the sponsor and FDA can go about conducting efficient, consistent, timely and effective ...
DEA and HHS Extend Telehealth Flexibilities for Controlled …
2024年1月10日 · The Drug Enforcement Administration (DEA) and the HHS announced they will extend pandemic-era telehealth prescribing flexibilities for controlled substances through 2024. The temporary extension marks the second time regulators have prolonged the rel
PhRMA Announces Updated Code on Interactions with Health …
On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) released its updated Code on Interactions with Health Care Professionals, a voluntary code of ethics that applies to pharmaceutical company interactions with United States health care professionals. As a member of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the PhRMA ...
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Johnson and Johnson 2013 Settlement and Corporate Integrity …
On November 4, 2013, the Department of Justice (DOJ) announced that Johnson & Johnson (J&J) and its pharmaceutical subsidiaries signed settlement agreements to pay more than $2.2 billion to resolve criminal and civil investigations into unapproved, or “off-label,” promotion of three drugs and alleged kickbacks to physicians and nursing home pharmacies over a ten-year period.
California Passes Senate Bill 1419 Law to Revise ... - Policy
2022年10月6日 · On September 30th Governor Newsome signed Senate Bill 1419, legislation sponsored by the California Medical Association and focused on providing physicians the opportunity to respect patient privacy and wishes when releasing their protected health information.. While the 21 st Century Cures Act Information Blocking Rule has allowed patients much greater access to their health care data, this ...
New York is the Latest State to Allow Full Practice Authority for …
2022年5月25日 · On April 11, 2022, New York Governor Kathy Hochul signed the state budget into law, which includes reforms surrounding services that health care workers are allowed to provide and will allow nurse practitioners full practice authority.New York joined with 24 other states, the District of Columbia, and two United States territories in …
Policy & Medicine – Legal, Regulatory, and Compliance Issues
Legal, Regulatory, and Compliance Issues. On October 8, 2024, PhRMA held a media briefing to address growing concerns over the Inflation Reduction Act (IRA) and its effects on the biopharmaceutical industry, Medicare Part D beneficiaries, and future drug innovations.