Regulatory Affairs

17
Jun

Halfway Through June 2021, Approval Actions Appear to Hit Sub-Par Numbers

We have reached the halfway mark of June and, as of the unofficial reporting through June 15th,OGD has issued just 24 full approval actions and 7 tentative approval actions.  Two ANDAs received partial full approval with at least one other strength receiving tentative approval, likely because of patent or exclusivity issues. The count for the […]

Read More
10
Jun

OGD Provides Updates to the April 2021 Statistical Report

The Office of Generic Drugs (OGD) filled in the blanks on its April Generic Drugs Program Activities Report – Monthly Performance (here) and here are the highlights of some of the important numbers. OGD issued refuse-to-receive (RTR) to three (3) ANDAs, all of which were for standard review ANDA submissions, while acknowledging seventy (70) new […]

Read More
02
Jun

Don’t Get a Swelled Head, Feeding Tube Guidance Straightens Out Requirements

Today, the FDA released its draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry (here). There have been numerous cases of clogging or otherwise blocking of enteral naso-gastric (N-G) feeding tubes when medication is administered due to a number of different reasons:  swelling of […]

Read More
27
May

Is This the Beginning of Withdrawal of the Withdrawal of the Unapproved Drug Initiative?

In a Federal Register notice today (here), the FDA blasted the HHS under the previous administration for withdrawing the Unapproved Drug Initiative (UDI), citing misstatements, errors of law, and fundamental untruths in the original Federal Register notice, published on November 25, 2020, titled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for […]

Read More
24
May

Wait a Minute, How Do We Go from Eliminating Drug Efficacy to Reduced Patent Terms… and Does Anyone Really Benefit?

I cringed while reading the opening two paragraphs of the article (here) written by Lawrence J. McQuillan in The Hill titled “How a reformed FDA can speed up delivery of lifesaving drugs”: The Biden administration favors a proposal to waive patent protections for the COVID-19 vaccines.  But there are other ways to remove impediments to […]

Read More
20
May
Old wagon in the desert

While Not Entirely New – Guidance Places Stamp of Approval on Some Synthetic Peptides Where the RLD is of rDNA Origin

For the last 5 or so years, the FDA has told applicants that they could likely submit an ANDA for a synthetic peptide product (40 amino acid chains or fewer) when the reference listed drug (RLD) was of rDNA origin but the guidance on which products, how, and what would be required was often sketchy.  […]

Read More
19
May

New Complex Generics PSGs Planned as Well as Some Revisions

Today, the FDA debuted a new page on their website called Upcoming Product-Specific Guidances for Complex Generic Drug Product Development.  Its stated purpose is to provide “information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.”  This comes after several public […]

Read More
1 2 121