RX Drugs, OTC Drugs and Biologics

The U.S. Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety, efficacy, and security of drugs marketed in the United States. All drugs, ranging from over-the-counter medications to prescription drugs, must receive FDA approval prior to marketing and sale in the U.S. This process involves a rigorous evaluation to verify that a drug is safe and effective for its intended use and that it is manufactured according to FDA quality standards. The FDA’s regulatory oversight extends to the entire drug lifecycle, encompassing clinical trials, manufacturing processes, marketing, and post-market surveillance.

In contrast to pharmaceutical drugs, biologics are a category of medicinal products that are derived from living organisms or contain components of living organisms. Unlike traditional pharmaceuticals that are chemically synthesized and have a well-defined structure, biologics are isolated from a variety of natural sources and may be produced by biotechnology methods and other cutting-edge technologies. They include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

Biologics are used to prevent, treat, or cure a variety of diseases and medical conditions, including cancer, rheumatoid arthritis, multiple sclerosis, and diabetes. Due to their complexity and the biological variation in the starting materials used in their production, biologics are generally more challenging to characterize and produce than small molecule drugs. Additionally, the regulatory approval process for biologics involves stringent requirements for demonstrating safety, purity, and efficacy, often including detailed data on manufacturing processes and facilities.

At Asebey Life Science Law, we specialize in guiding clients through the complex regulatory landscape of drug and biologics product development and approval, licensing and compliance. Our team offers expert legal support for New Drug Application (NDA), Abbreviated New Drug Application (ANDA), 505(b)(2) application, Biological License Application (BLA), and Biosimilar approval license applications to FDA.

Services Provided

Support for NDA, ANDA, 505(b)(2) and BLA submissions to FDA
Advertising and label compliance services
FDA Warning Letters and 483 responses to FDA
Recall and crisis management services
IP licensing matters
Preparation for FDA facility inspection
IND preparation and submission to FDA
Pre-IND meeting preparation
Development of FDA approval / licensing strategy
Removal from FDA Import Alert
Regulatory opinions regarding approval pathways for novel therapeutics
Current Good Manufacturing Practices (CGMP) compliance
Regulatory due diligence in support of capital raise or M&A event
Post-acquisition integration of quality systems
Guidance on Orphan Drug and Priority Review Voucher (PRV) qualification
OTC listing services
Compliance with chemistry, manufacturing, and control (CMC)

Representative Matters

Advised Abbott Laboratories on FDA compliance matters in its capitalization and option to purchase Cephea Technologies
Conducted regulatory due diligence on French pharmaceutical company HRA Pharma in connection to the company’s sale to Goldman Sachs and Astorg Partners
Advised a U.S. biopharmaceutical company on the potential sale of option rights to a pediatric priority review voucher (PRV)
Provided regulatory compliance services to a $2.4 billion hospital group on FDA and state health care laws governing the commercialization of de-identified human solid and liquid tissue
Advised and negotiated on behalf of a European API manufacturer a $94 million IP licensing and supply agreement with a prominent U.S. medical foods company
Negotiated IP licensing agreement and sponsored research agreement between a biotech client company and Brigham and Women’s Hospital/Harvard University
Assisted the U.S. subsidiary of a European biotech company in creating a Scientific Advisory Board
Performed regulatory and IP due diligence on various psychedelic biotech ventures on behalf of Iter Investments, a venture capital fund
Provided clinical trial and FDA regulatory advisory services to a U.S. biopharmaceutical venture developing psilocybin-derived therapeutics for various mental health indications
Represented a U.S. stem cell company in responding to an FDA Warning Letter
Advised several companies on marketing compounded semaglutide and trizepatide drug products
Retained by the United Nations Industrial Development Program (UNIDO) to assist Latin American cosmetics & OTC product manufacturers with FDA regulatory compliance
Advised a U.S. generic drug company on FDA compliance when importing API from India
Advised a Brazilian biologics company on the §351(k) pathway for licensing a biosimilar
Assisted a Latin American pharmaceutical company with OTC listings and advertising compliance matters
Represented an OTC drug company in responding to an FDA Warning Letter
Prepared a Spanish API manufacturer for its first FDA inspection

Tell us more about your regulatory needs so we can help you succeed.

Request a consultation