The US Food and Drug Administration (FDA) criticized a Turkish manufacturer of over-the-counter drugs for failing to test incoming ingredients and to test products before releasing them to the market in a recent warning letter . The company was also warned for its lax approach to stability testing.   The 13 May letter to Istanbul-based Gulsah Uretim Kozmetik Sanayi Anonim Sirketi follows up on FDA’s review of a 23 April response to request for records. The firm is the...

The US Food and Drug Administration (FDA) on Monday released the commitment letter outlining performance goals and procedures for the upcoming reauthorization of the Prescription Drug User Fee Amendments for FYs 2023-2027 (PDUFA VII).   The agency also announced a public meeting on the reauthorization, scheduled for the afternoon of 28 September. Registration for the meeting, which will be held virtually, is free.   Many of the concepts and programs the agency di...

The US Food and Drug Administration’s (FDA’s) Office of Generic Drugs recently issued a revised Manual of Policies and Procedures (MAPP) describing the agency’s internal procedures for handling generic drug labeling changes, including listing the responsibilities of the internal FDA staff responsible for managing these labeling changes.   The 16-page MAPP implements Section 10609 the Patient Protection and Affordable Care Act (PPACA) which was enacted in 2010 and add...

The European Medicines Agency (EMA) has adopted a guideline on the quality information that manufacturers of combination products should submit in marketing authorization applications (MAA).   It also incorporates the recent revision of the EU’s Medical Devices Regulations (MDR) in requiring makers of these products to obtain the results of conformity testing of the device part from a notified body. The MDR regulation went into effect in May 2021. (RELATED: EMA Kicks...

The US Food and Drug Administration has issued new draft guidance for clinical trials examining the adhesion performance of transdermal and topical delivery systems (collectively, TDS) for new drug applications.   Surface area is an important variable in determining the amount of drug delivered through a TDS; adhesion performance can affect both safety and effectiveness of TDS products because adhesion failures can result in reduced effectiveness caused by suboptimal d...

With few comprehensive resources available covering combination products, RAPS’ recently released book, International Combination Products , by Jocelyn Jennings, MS, RAC (US, Drugs, Devices), fills a significant need for practical guidance on navigating the regulatory pathways for products combining multiple technologies. Prior to writing the book, “there was no place that I found that I could look to find all of the information I was interested in on different topics t...

A newly finalized guidance on bispecific antibodies from the US Food and Drug Administration (FDA) notes that although bispecific antibodies can generally be characterized in the same ways as standard monoclonal antibodies and manufacturing processes may be similar, some scientific and regulatory considerations are unique to bispecifics.   According to a 24 May agency announcement , while the regulatory pathway for evaluating monoclonal antibodies is “well established...

Final guidance from the US Food and Drug Administration (FDA) specifies when sponsors must conduct pediatric studies for new cancer drugs as well as when those requirements can be waived or deferred.   Sponsors are required to evaluate these oncology drugs in pediatric populations for applications submitted on or after 18 August 2020, under changes made by the FDA Reauthorization Act of 2017 (FDARA).   The guidance addresses molecularly targeted oncology drugs for ...

The US Food and Drug Administration (FDA) issued a final guidance on its criteria for accepting abbreviated new drug applications for synthetic peptide drugs of recombinant DNA (rDNA) origin.   The guidance is meant to spur the development of these complex drugs.  The agency also rejected industry calls to eliminate the impurity limit thresholds for accepting these submissions as abbreviated new drug applications (ANDAs).   The guidance, which finalizes 2017 draft ...

The US Food and Drug Administration (FDA) on Wednesday issued 13 new and eight revised draft product-specific guidances intended to facilitate the development of generic drugs.   The guidances are intended to foster generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug (RLD). FDA’s current count of product-specific guidances sits at 1,896 with this latest release....

Navigating the re-consultation process for drug-device combination products under EU’s new Medical Device Regulation can be tricky business, said panelists during a session at Euro Convergence 2021.   Speakers at the combination products-focused session shared experiences and highlighted gaps where manufacturers still need clarity from competent authorities, who themselves are feeling the strain of implementing new regulations while they continue to sort out post-Brexi...

A strong local presence in EU markets is needed when seeking labelling exemptions that help reduce the cost of providing orphan products, according to experts who spoke at RAPS Euro Convergence 2021.   Manufacturers of orphan drugs can gain exemptions from some labelling requirements at an EU level and from individual member states, a potentially valuable flexibility for companies that make orphan drugs targeting very small numbers of patients. Such products face speci...