29
Jul
ruler

OGD Quarterly Activities Report – Look What’s Going On!

In the Generic Drug User Fee Amendments Reauthorization Act (GDUFA II), OGD committed to provide a quarterly report with certain metrics regarding their workload and mean and median approval times for full approval actions and tentative approval actions. As you can see from the numbers below, the number of ANDAs awaiting action at OGD is […]

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22
Jul
Male hand holding megaphone with it s time to start speech bubble. Loudspeaker. Banner for business, marketing and advertising. Vector illustration.

Virtual Public Meeting Generic Drug User Fee Amendments – A Perspective for GDUFA III

On Tuesday from 9:00-3:00 PM, the FDA held a virtual public meeting to obtain initial input from federal agencies, healthcare organizations, industry trade associations and other stakeholders in general on the reauthorization preparations for the third iteration of GDUFA.  It is not known whether FDA will provide a link to the virtual program, as it […]

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20
Jul
Hooray

Proposed Law Would Provide pathway for Generic Drugs Labeling Changes with a Reasoned Approach

Proposed Law Would Provide Pathway for Generic Drugs Labeling Changes with a Reasoned Approach Proposed H.R. 5668 (here) titled, Making Objective Drug Evidence Revisions for New Labeling Act of 2020, outlines a path forward for making generic drug labeling changes when the reference listed drug is no longer marketed.  We all understand the history of […]

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10
Jul
Wolf howling to the moon

Domestic Priority Inspections to Restart on July 20 – With Conditions

FDA announced a target date for the resumption of prioritized domestic facility inspections beginning on July 20, 2020.  The Full FDA announcement can be found here. FDA points out that they will be closely watching the trajectory of COVID-19 cases by area, as well as other logistical factors (i.e., public transportation) and will make decisions […]

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10
Jul
RIP Headstone

PETN Dead for Good After Final DESI Hearing Decision and Exceptions Are Deemed Withdrawn

The story started in 1962 with the congressional passage of the Kefauver-Harris Amendments that added efficacy requirements for all new drug approvals.  For those products approved for safety only during the period from 1938 to 1962, an evaluation of efficacy of those products was undertaken in the Drug Efficacy Study Implementation (DESI) program.  The DESI […]

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29
Jun
Close up of female student study using handbooks writing notes

REMS – Revision 2 Adds Updates to Previous Two Versions

The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2.  Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]

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01
May
Warning sign

Black Box Warning Added to Singulair and Montelukast Generics Labeling

The FDA has added a Black Box warning to the popular drug montelukast (brand name Singulair).  A black box warning is one of FDA’s most significant label warnings, and in this case, there are recommendations to potentially change therapeutic decisions based on the severity of the diseases and the potential risk benefit The new warning […]

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27
Jan

Competitive Generic Therapy Approvals Listed by FDA

The FDA has provided a list of all products approved under the Competitive Generic Therapy (CGT) designation program under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This exclusivity is awarded for products with limited generic competition and provides for a potential 180-day exclusivity marketing period. On its current list (here), […]

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27
Jan

Scott Deckebach, M.B.A., new Director in the Compliance Practice at Lachman Consultant Services, Inc.

We are pleased to announce that Scott Deckebach has accepted the position of Director in the Compliance Practice at Lachman Consultants, effective January 27, 2020. Mr. Deckebach is a life sciences and medical device regulatory compliance, manufacturing, and technology expert with more than 25 years of experience in the industry. Mr. Deckebach has been affiliated […]

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