16
May

FDA Issues Next Batch of New and Revised PSGs 

Today, the FDA issued twenty-six new and six revised Product Specific Guidances (PSGs) (here).  PSGs provide the Agency’s current thinking on acceptable methods for demonstrating bioequivalence between the Reference Listed Drug or the Reference Standard designated by the Agency (if the RLD is no longer available) and the proposed generic product.  These latest PSG additions […]

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30
Apr
More on the Final Rule on ANDAs and 505(b)(2) Applications Image

Final Rule on IVDs Issued, Along with Two Guidance Documents 

FDA has finalized its long-awaited Final Rule on Medical Devices; Laboratory Developed Tests (here).  This Rule has been percolating within the Agency for a while and is the final step since the Proposed Rule was issued October 3, 2023.  FDA explains that since  “1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C […]

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02
Apr

Ophthalmic Drug Product PSG Publishes Under Unusual Circumstances 

Today, the FDA published a Product Specific Guidance (PSG) with recommendations for establishing bioequivalence of oxymetazoline hydrochloride ophthalmic solution (here).  As we have all recognized through the publication of numerous other PGSs over the last five years, the Agency is moving to BE waivers to establish sameness of the product as well as meet the […]

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28
Mar

FDA Sets OTC Drug Monograph Facility User Fee Rates for Fiscal Year (FY) 2024 and They Are UP! 

Section 744M of the FD&C Act (21 U.S.C. 379j-72), authorizes the FDA to assess and collect: (1) facility fees from qualifying owners of OTC monograph drug facilities and (2) fees from submitters of qualifying OTC Monograph order requests(OMORs).  OMOR fee rates for Fiscal Year (FY) 2024 were published on September 12, 2023 (see blog post […]

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27
Mar

FDA Warns of Danger for Unapproved Topical Products Containing Lidocaine 

In a press release issued yesterday (here), the FDA warned six companies about topical lidocaine products that can cause serious health effects and are also unapproved new drugs.  The products are recommended for use after certain dermatological procedures “such as microdermabrasion, laser hair removal, tattooing and piercing.”  These products are being marketed at concentrations above […]

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26
Mar

FDA Lowers the Number of Required BA/BE Reserve Samples in Revised Guidance 

The number of reserve samples required by current regulations has been a sore subject for both NDA and ANDA sponsors as well as testing facilities as the cost and storage requirements for the required reserve samples of both test and reference product was overly burdensome.  Now, after twenty years of concern expressed by the industry, […]

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04
Mar

Narrow Therapeutic Index Drugs, Generics, and Better Education  

FDA published a conversation piece on narrow therapeutic index drugs entitled, “Setting and Implementing Standards for Narrow Therapeutic Index Drugs” (here ) to better inform health care professionals (HCP), patients, and other consumers regarding the use of and how the FDA treats narrow therapeutic index (NTI) drugs.  Let’s look at what an NTI drug is […]

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