01
Jul

FDA Issues Two New Labeling Guidances to Aid Sponsors

The FDA announced the availability of two draft labeling guidance documents today.  One, titled Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format (for standardizing the instructions for use section of labeling), and the other, titled Drug Abuse and Dependence Section of Labeling for Human […]

Read More
26
Jun

The Agency Speaks to Its Effort for Modernizing FDA’s New Drugs Regulatory Program

Today, in the Federal Register (here), the FDA announced a portion of its continuing modernization plan relative to better assessing its summary of approval that FDA prepares for all new NDA and BLA approvals. The notice asked for public comment on “the Clinical Data Summary Report Pilot program as part of the Agency’s continuous assessment […]

Read More
20
Jun
Someone in pain

Opioids Front and Center as FDA Issues Notice of Public Hearing and New Draft Guidance

In two separate Federal Register (FR) notices today, the FDA announced a public hearing (here) to be held on September 17, 2019.  The notice states: This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, […]

Read More
19
Jun
Cannabis plant

FDA and Cannabinoids – The Betwixt and Between – Public Comment Period Extended Two Weeks

The cat is out of the bag and so are CBD and other cannabis products.  You can find CBD in almost anything (creams, ointments, lotions, foods, supplements) and almost everywhere, including gas stations, 7-Elevens, supermarkets, flea markets, and fairs, etc.  I am certain that Amazon drones will be dropping it off at your front door […]

Read More
19
Jun
Enhancements

Enhancement to the Paragraph IV Database to Aid Generic Applicants and Provide Greater Transparency

Having lived through the days at FDA when sponsors called the FDA asking if anyone had submitted a Paragraph IV patent challenge for a specific drug and was thus potentially eligible for 180-day exclusivity as being a first-to-file applicant, the move to the PIV database was a godsend as it took the pressure off us […]

Read More
13
Jun

Official Approval, Receipt, and Complete Response Numbers for May and June Slow Out of the Box for ANDA Approvals

The Office of Generic Drugs released its first set of metrics this morning for May which shows (as previously reported here),  83 full approval actions and 12 tentative approval actions (1 more in each category than estimated in the post cited above), for a total of 95 approval actions.  This is the first time this […]

Read More
1 7 8 9 98