Calendaring Drafting Manufacturing 
FDA Law Blog
NOVEMBER 14, 2022
2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. Livornese — Early Nov.
FDA Law Blog
SEPTEMBER 6, 2023
Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.
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FDA Law Blog
AUGUST 14, 2024
Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. CMS will develop a new online portal for manufacturers to review their reports, submit Suggestions of Error, and make rebate payments.
FDA Law Blog
SEPTEMBER 27, 2023
And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance.
Broadcast Law Blog
FEBRUARY 27, 2023
At its March 16 regular monthly open meeting, the FCC will consider a draft Further Notice of Proposed Rulemaking (“FNPRM”) that, if adopted, would formally propose to extend the FCC’s existing audio description requirements for broadcast television to DMAs below the top 100 (i.e., DMAs 101-210). and 11:59 p.m. local time.
Customs & International Trade Law
APRIL 29, 2022
Food and Drug Administration ( FDA ) announced the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry. CBP officers determined that the rings had a total Manufacturers Suggested Retail Price (MSRP) value of approximately $15,000.
MyCase
AUGUST 8, 2022
One of a SaaS lawyer’s most important duties is drafting and reviewing contracts and agreements. For example, if a software company wants to work with a new client, their lawyer can draft a SaaS agreement outlining the terms of the relationship. Contracts and Agreements . Renewals and auto renewals . Termination . Dispute resolution .
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