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FDA
FDA to Focus on Patients with Rare Diseases
On March 5, 2020, in recognition of Rare Disease Day, the United States Food and Drug Administration (FDA) held a conference…
2020 OPDP Year-in-Review
The United States Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research’s (CDER) Office of Prescription…
FDA Meets All Goal Dates for 2020 Drug Approvals
In 2020, the United States Food and Drug Administration (FDA) not only met all goal dates for approvals by the Center for Drug…
FDA Issues Guidance on STeP
Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance for devices and combination products,…
Review of 2020 FDA Enforcement Activities
Recently, the attorneys at Ropes & Gray wrote an article reviewing the United States Food and Drug Administration’s (FDA) 2020…
FDA Releases Draft Guidance on IND Submissions for Individualized Antisense…
Earlier this year, the United States Food and Drug Administration (FDA) issued draft guidance surrounding investigational new drug…
Industry Seeks Clarity on Interchangeability for BsUFA III
Towards the end of last year, the United States Food and Drug Administration (FDA) opened a public docket to solicit comments on…
FDA Releases Final Guidance Under GDUFA II
In mid-December 2020, the United States Food and Drug Administration finalized updated guidance to generic drug manufacturers. The…
FDA Issues Draft Guidance on Proprietary Names
The U.S. Food and Drug Administration (FDA) issued a pair of draft guidance documents aimed at guiding the selection of…
OPDP Sends Six Warning and Untitled Letters in 2020 – Final Letter Sent to…
At the end of November 2020, the Office of Prescription Drug Promotions (OPDP) sent its sixth – and final – letter of the year to…