Tag Archives: manufacturers

New Jersey Attorney General Loosens Rules on the Acceptance by Prescribers of Remuneration from Drug Manufacturers

By Alan M. Kirschenbaum — Responding to objections from New Jersey healthcare practitioners, hospitality and restaurant businesses, and the pharmaceutical industry, the New Jersey Attorney General published an amendment to the state’s rules restricting the acceptance of remuneration by prescribers … Continue reading

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Poppy Seeds can Kill – Manufacturers and Retailers be Forewarned

The State of Arkansas is stepping up as a leader and pushing responsible retailers to stop selling a defective and potentially deadly product. Hopefully the FDA will act as well as the DEA. Manufacturers and retailers be forewarned; if you … Continue reading

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Marijuana Manufacturers, Site Owners, May be Subject to New Problem: Exploding Factories

As attorneys representing marijuana companies and workers in Los Angeles, we urge them to carefully analyze every aspect of the business plan – including safety. Now, a safety issue previously believed to be fluke with marijuana manufacturers appears to be … Continue reading

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Pharmaceutical Manufacturers Must Submit 340B Ceiling Prices Starting in the First Quarter of 2019

By David C. Gibbons & Alan M. Kirschenbaum — Beginning February 15, drug manufacturers will have a new price to report to the Federal government: 340B ceiling price.  Under Section 340B of the Public Health Service Act, a manufacturer of … Continue reading

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FDA is “Discouraged” by Dearth of HCT/P Manufacturers that have Reached Out to Agency During Enforcement Discretion Period

By Mark I. Schwartz — In November of 2017, FDA published its enforcement discretion policy regarding HCT/Ps that don’t meet all four criteria under 21 CFR 1271.10(a): To give manufacturers time to determine if they need to submit an IND … Continue reading

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