7: The Regulation of Biologics - Biology

7: The Regulation of Biologics - Biology

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  • Define biologic
  • Outline the approval process for biologics
  • Distinguish the different product categories CBER has regulatory authority
  • Differentiate between a drug, biologic, generic drug, reference product, and biosimilar
  • 7.1: Introduction to Biologics
    Biologics are revolutionizing the biotechnology and health sector – and the most important biotechnology products of this century. Biologics include vaccines, tissue transplants, gene therapy, & stem cell treatment and may include biological molecules such as proteins, and nucleic acids, living tissues, and cells. Some biologics treat a disease or disorder, and some diagnose or prevent them.
  • 7.2: The Center for Biologics, Evaluation, and Research
    The Center for Biologics, Evaluation & Research (CBER) is the primary Center in the FDA, which oversees the regulation of biologic & related products. We will explore in this chapter the broad range of biological products CBER reviews. There are three main review offices in CBER; Office of Blood Research and Review (OBRR); Office of Cellular, Tissue and Gene Therapies (OCTGT); and the Office of Vaccine Research and Review (OVRR).
  • 7.3: Processes for Drug Approval
    The FDA regulates clinical studies in the US, and unapproved drugs and biologics must be conducted under an Investigational New Drug Application (IND). The IND is continually updated with new protocols, study data, and annual reports. The IND for a biologic must contain administrative information, preclinical research results, any previous human experience with the drug, and the clinical protocol. The IND is never approved; rather, it is pending, active, on hold, or partial hold.
  • 7.4: Office of Compliance & Biologics Quality (OCBQ)
  • 7.5: Labeling
    Labeling here is referring to the display of written or printed material on the container or an enclosed document. Labeling includes both FDA approved labelings such as container labels, professional labeling in the package insert (PI – prescribing information), patient labeling (PPI – patient package inserts), medication guides, and instructions for use. But also, any promotional material.

42 U.S. Code § 262 - Regulation of biological products

No person shall interfere with any officer, agent, or employee of the regulations made by authority thereof.

Any person who shall violate, or aid or abet in violating, any of the provisions of this section shall be punished upon conviction by a fine not exceeding $500 or by imprisonment not exceeding one year, or by both such fine and imprisonment, in the discretion of the court.

Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

Any person may submit an application for licensure of a (2) Content

An application (or a supplement to an application) submitted under this subsection may include information demonstrating that the (3) Evaluation by Secretary Upon review of an application (or a supplement to an application) submitted under this subsection, the (A) the (i)

An application submitted under this subsection shall be reviewed by the division within the Food and Drug Administration that is responsible for the review and approval of the application under which the (C) Risk evaluation and mitigation strategies

Approval of an application under this subsection may not be made effective by the (B) Filing period

An approved application that is deemed to be a license for a Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection (a) for purposes of subparagraphs (A) and (B).

The exclusivity periods described in section 527, section 505A(b)(1)(A)(ii), and section 505A(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360cc and 355a(b)(1)(A)(ii), (c)(1)(A)(ii)] shall continue to apply to aBiologics Price Competition and Innovation Act of 2009.

The issuance (or non-issuance) of guidance under subparagraph (A) shall not preclude the review of, or action on, an application submitted under this subsection.

Clause (i) shall not be construed to require the (l) Patents

Unless otherwise agreed to by a person that submits an application under subsection (k) (referred to in this subsection as the “subsection (k) applicant”) and the sponsor of the application for the (B) In general

When a subsection (k) applicant submits an application under subsection (k), such applicant shall provide to the persons described in clause (ii), subject to the terms of this paragraph, confidential access to the information required to be produced pursuant to paragraph (2) and any other information that the subsection (k) applicant determines, in its sole discretion, to be appropriate (referred to in this subsection as the “confidential information”).

One or more attorneys designated by the (II) In-house counsel

One attorney that represents the (iii) Patent owner access

A representative of the owner of a patent exclusively licensed to a (C) Limitation on disclosure

No person that receives confidential information pursuant to subparagraph (B) shall disclose any confidential information to any other person or entity, including the (D) Use of confidential information

Confidential information shall be used for the sole and exclusive purpose of determining, with respect to each patent assigned to or exclusively licensed by the (E) Ownership of confidential information

The confidential information disclosed under this paragraph is, and shall remain, the property of the subsection (k) applicant. By providing the confidential information pursuant to this paragraph, the subsection (k) applicant does not provide the (F) Effect of infringement action

The disclosure of any confidential information in violation of this paragraph shall be deemed to cause the subsection (k) applicant to suffer irreparable harm for which there is no adequate legal remedy and the court shall consider immediate injunctive relief to be an appropriate and necessary remedy for any violation or threatened violation of this paragraph.

Not later than 60 days after receipt of the list and statement under subparagraph (B), the (4) Patent resolution negotiations

After receipt by the subsection (k) applicant of the statement under paragraph (3)(C), the (B) Failure to reach agreement

If, within 15 days of beginning negotiations under subparagraph (A), the subsection (k) applicant and the (5) Patent resolution if no agreement

The subsection (k) applicant shall notify the (B) Exchange of patent lists

Subject to subclause (II), the number of patents listed by the (II) Exception

If a subsection (k) applicant does not list any patent under clause (i)(I), the (6) Immediate patent infringement action

If the subsection (k) applicant and the (B) Action if no agreement on patent list

If the provisions of paragraph (5) apply to the parties as described in paragraph (4)(B), not later than 30 days after the exchange of lists under paragraph (5)(B), the (C) Notification and publication of complaint

Not later than 30 days after a complaint is served to a subsection (k) applicant in an action for patent infringement described under this paragraph, the subsection (k) applicant shall provide the (ii) Publication by Secretary

If a subsection (k) applicant provides the application and information required under paragraph (2)(A), neither the section 2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent that is described in clauses (i) and (ii) of paragraph (8)(B).

If a subsection (k) applicant fails to complete an action required of the subsection (k) applicant under paragraph (3)(B)(ii), paragraph (5), paragraph (6)(C)(i), paragraph (7), or paragraph (8)(A), the section 2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent included in the list described in paragraph (3)(A), including as provided under paragraph (7).

If a subsection (k) applicant fails to provide the application and information required under paragraph (2)(A), the section 2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent that claims the biological product.

The provisions of subsections (a), (d), (e), (f), (h), (i), (j), (k), (l), (n), and (p) of section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a(a), (d), (e), (f), (h), (i), (j), (k), (l), (n), (p)] shall apply with respect to the extension of a period under paragraphs (2) and (3) to the same extent and in the same manner as such provisions apply with respect to the extension of a period under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a(b), (c)].

The 21 U.S.C. 355a(d)(4)] is made later than 9 months prior to the expiration of such period.

In the case of an application under subsection (a) with respect to a Controlled Substances Act [21 U.S.C. 801 et seq.], approval of such application shall not take effect until the interim final rule controlling theControlled Substances Act [21 U.S.C. 811(j)].

The effective date of this paragraph, referred to in subsec. (d)(2), is the effective date of section 315 of Pub. L. 99–660 which added subsec. (d)(2). See Effective Date of 1986 Amendment note set out below.

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (g), (h), (j), and (k)(5)(C), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.

Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009, referred to in subsec. (k)(7)(D), is section 7002(e)(4) of Pub. L. 111–148, which is set out as a note under this section.

Sections 526, 527(a), and 505A(d)(4), referred to in subsec. (m)(2)(B), (3)(B), (4), probably mean sections 526, 527(a), and 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, which are classified to sections 360bb, 360cc(a), and 355a(d)(4), respectively, of Title 21, Food and Drugs.

The Controlled Substances Act, referred to in subsec. (n)(1), is title II of Pub. L. 91–513, Oct. 27, 1970 , 84 Stat. 1242, which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Short Title note set out under section 801 of Title 21 and Tables.

2019—Subsec. (i)(1). Pub. L. 116–94, § 605, struck out “(except any chemically synthesized polypeptide)” after “protein”.

2017—Subsec. (m)(2) to (4). Pub. L. 115–52 substituted “section 505A(d)(4)” for “section 505A(d)(3)”.

2016—Subsec. (a)(2)(E). Pub. L. 114–255 added subpar. (E).

2015—Subsec. (n). Pub. L. 114–89 added subsec. (n).

2012—Subsec. (m)(1). Pub. L. 112–144 substituted “(f), (h), (i), (j), (k), (l), (n), and (p)” for “(f), (i), (j), (k), (l), (p), and (q)”.

2010—Subsec. (a)(1)(A). Pub. L. 111–148, § 7002(a)(1), inserted “under this subsection or subsection (k)” after “biologics license”.

Subsec. (i). Pub. L. 111–148, § 7002(b), substituted “In this section:” for “In this section,”, designated remainder of existing provisions as par. (1), substituted “The term” for “the term”, inserted “protein (except any chemically synthesized polypeptide),” after “allergenic product,”, and added pars. (2) to (4).

Subsec. (j). Pub. L. 110–85, § 901(c)(2), inserted “, including the requirements under sections 505(o), 505(p), and 505–1 of such Act,” after “and Cosmetic Act”.

2003—Subsec. (a)(2)(B), (C). Pub. L. 108–155 added subpar. (B) and redesignated former subpar. (B) as (C).

1997—Subsec. (a). Pub. L. 105–115, § 123(a)(1), amended subsec. (a) generally. Prior to amendment, subsec. (a) related to intrastate and interstate traffic inPub. L. 105–115, § 123(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) read as follows: “No person shall falsely label or mark any package or container of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product aforesaid nor alter any label or mark on any package or container of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product aforesaid so as to falsify such label or mark.”

Subsec. (c). Pub. L. 105–115, § 123(c), substituted Pub. L. 105–115, § 123(a)(2), designated par. (2) as subsec. (d), redesignated subpars. (A) and (B) of par. (2) as pars. (1) and (2), respectively, in par. (2), substituted “Any violation of paragraph (1)” for “Any violation of subparagraph (A)” and substituted “this paragraph” for “this subparagraph” wherever appearing, and struck out former par. (1) which read as follows: “Licenses for the maintenance of establishments for the propagation or manufacture and preparation of products described in subsection (a) of this section may be issued only upon a showing that the establishment and the products for which a license is desired meet standards, designed to insure the continued safety, purity, and potency of such products, prescribed inPub. L. 105–115, § 123(d), added subsec. (i).

1996—Subsec. (h). Pub. L. 104–134, § 2104, amended subsec. (h) generally, revising and restating former provisions, which also related to exportation of partially processedPub. L. 104–134, § 2102(d)(2), substituted “in a country listed under section 802(b)(1)” for “in a country listed under section 802(b)(A)” and “to a country listed under section 802(b)(1)” for “to a country listed under section 802(b)(4)”.

1992—Subsec. (c). Pub. L. 102–300, which directed substitution of “Health and HumanPub. L. 99–660, § 315, designated existing provisions as par. (1) and added par. (2).

1970—Subsecs. (a) to (c). Pub. L. 91–515 inserted “vaccine, blood, blood component or derivative, allergenic product,” after “antitoxin” wherever appearing.

Amendment by Pub. L. 110–85 effective 180 days after Sept. 27, 2007 , see section 909 of Pub. L. 110–85, set out as a note under section 331 of Title 21, Food and Drugs.

Amendment by Pub. L. 108–155 effective Dec. 3, 2003 , except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an Effective Date note under section 355c of Title 21, Food and Drugs.

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997 , except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of Title 21, Food and Drugs.

Amendment by section 315 of Pub. L. 99–660 effective Dec. 22, 1987 , see section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title.

References to section 3501 of this title, which transferred all functions of Federal Security Administrator toDepartment of Health and Human Services by section 509(b) of Pub. L. 96–88 which is classified to section 3508(b) of Title 20.

[Amended sections 175, 177, and 178 of Title 18, Crimes and Criminal Procedure.]

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Synthetic biology is an emerging technology with potential benefits to various fields, yet also contains potential risks to human and environmental health. The field remains in an emerging state with limited quantitative guidance and a small but growing population of international researchers that conduct work within this field. Given the uncertain nature of this technology, an adaptive and anticipatory governance framework may be necessary to balance the potential benefits that may accrue from the technology's continued research alongside a desire to reduce or eliminate potential risks that may arise. However, such developments must account for the unique political and institutional factors that form a government's risk culture - something that can facilitate or impede the development of adaptive synthetic biology governance moving forward. The TAPIC framework helps illustrate those factors that are essential to develop good governance for emerging technologies like synthetic biology. Specifically, an application of TAPIC to synthetic biology governance indicates that the factors of accountability, participation, and integrity must be bolstered to improve technology governance in governments like with the United States, European Union, and Singapore.


Although CD20 is considered to be an ideal therapeutic target and rituximab-based immunotherapy has become a standard of care for a majority of B-cell malignancies, it is still unclear what all the functions of CD20 are, and how its expression is regulated. The main reason is the large heterogeneity of patients with B-cell malignancies and the lack of mouse models with an evident phenotype which makes CD20 analysis in vivo more difficult. A full understanding of the complexity of regulation of CD20, its physiological function and the exact mechanism of action of anti-CD20 monoclonal antibodies is of pivotal importance to develop new modified anti-CD20 monoclonal antibodies and their therapeutic combination that would yield better clinical efficacy and/or less toxicity. Recently, the possible role of CD20 in microenvironmental interactions was underscored by the observation that CD20 is upregulated in the context of immune niches. This is likely to be of physiological importance, especially for BCR signaling however, it is unclear if this is related to the putative function of CD20 as a regulator of calcium flux triggered by BCR or any potential role in T-cell interactions or some additional function(s). Further investigation of the physiological function of CD20 is required, including the identification of molecules that interact with CD20, since this has implications for the development of rational therapeutic combinations and strategies.

7 U.S. Code § 7712 - Regulation of movement of plants, plant products, biological control organisms, noxious weeds, articles, and means of conveyance

The importation, entry, exportation, or movement in interstate commerce of any plant, plant product, biological control organism, noxious weed, article, or means of conveyance, if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States or the dissemination of a plant pest or noxious weed within the United States.

The plant pathogens into the United States associated with proposals toplant products into the United States.

In conducting the study the State departments of agriculture, colleges and universities, the private sector, and the Agricultural Research Service .

Not later than 2 years after June 20, 2000 , the Secretary shall submit a report on the results of the study conducted under this section to the Committee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Agriculture of the House of Representatives .

In the case of noxious weeds, the Secretary may publish, by regulation, a list of noxious weeds that are prohibited or restricted from entering the United States or that are subject to restrictions on interstate movement within the United States.

Any person may petition the plant species to, or remove a plant species from, the regulations issued by the (3) Duties of the Secretary

In the case of a petition submitted under paragraph (2), the (g) Biological control organisms

In the case of biological control organisms, the Secretary may publish, by regulation, a list of organisms whose movement in interstate commerce is not prohibited or restricted. Any listing may take into account distinctions between organisms such as indigenous, nonindigenous, newly introduced, or commercially raised.

Any person may petition the biological control organism to, or remove a biological control organism from, the regulations issued by the Secretary under this subsection.

In the case of a petition submitted under paragraph (2), the (Pub. L. 106–224, title IV, § 412, June 20, 2000 , 114 Stat. 441.)

This chapter, referred to in subsec. (d)(2)(E), was in the original “this title”, meaning title IV of Pub. L. 106–224, June 20, 2000 , 114 Stat. 438, known as the Plant Protection Act, which is classified principally to this chapter. For complete classification of title IV to the Code, see Short Title note set out under section 7701 of this title and Tables.

How You Will Learn

Undergraduate students in the program choose courses from among a wide range of research fields to both develop a solid foundation in biology and to build meaningful depth of study in areas of personal interest. In addition to formal lecture and lab courses, students have many opportunities for independent study through seminar courses and research with our outstanding faculty.

Graduate students can choose an MS or PhD program. Both programs stress the importance of the research experience and its value to critical thinking. Students choose from three research tracks, each with course requirements that aim to build depth of study in specific focal areas: Cellular and Molecular Biology, Ecology and Evolution, and Neurobiology.

The Department of Biological Regulation is comprised of approximately 160 people organized in 13 research groups. We are located in the Candiotty and Britannia buildings, which are equipped with all the facilities required for running excellent research.

Congratulations to Dr. Inna Solomonov on being promoted to Senior Staff Scientist

Congratulations to Dr. Rotem Ben Tov Perry on being promoted to Associate Staff Scientist

Congratulations to Prof. Irit Sagi on being awarded the 2020 ICS-Adama Prize for Technological Innovation- for her pioneering research on enzymatic processes using chemical and biophysical approaches, and for developing inhibitory proteins and antibodies to combat acute and chronic diseases.

The control of glycolysis begins with the first enzyme in the pathway, hexokinase ([link]). This enzyme catalyzes the phosphorylation of glucose, which helps to prepare the compound for cleavage in a later step. The presence of the negatively charged phosphate in the molecule also prevents the sugar from leaving the cell. When hexokinase is inhibited, glucose diffuses out of the cell and does not become a substrate for the respiration pathways in that tissue. The product of the hexokinase reaction is glucose-6-phosphate, which accumulates when a later enzyme, phosphofructokinase, is inhibited.

Phosphofructokinase is the main enzyme controlled in glycolysis. High levels of ATP, citrate, or a lower, more acidic pH decrease the enzyme’s activity. An increase in citrate concentration can occur because of a blockage in the citric acid cycle. Fermentation, with its production of organic acids like lactic acid, frequently accounts for the increased acidity in a cell however, the products of fermentation do not typically accumulate in cells.

The last step in glycolysis is catalyzed by pyruvate kinase. The pyruvate produced can proceed to be catabolized or converted into the amino acid alanine. If no more energy is needed and alanine is in adequate supply, the enzyme is inhibited. The enzyme’s activity is increased when fructose-1,6-bisphosphate levels increase. (Recall that fructose-1,6-bisphosphate is an intermediate in the first half of glycolysis.) The regulation of pyruvate kinase involves phosphorylation by a kinase (pyruvate kinase kinase), resulting in a less-active enzyme. Dephosphorylation by a phosphatase reactivates it. Pyruvate kinase is also regulated by ATP (a negative allosteric effect).

If more energy is needed, more pyruvate will be converted into acetyl CoA through the action of pyruvate dehydrogenase. If either acetyl groups or NADH accumulate, there is less need for the reaction and the rate decreases. Pyruvate dehydrogenase is also regulated by phosphorylation: A kinase phosphorylates it to form an inactive enzyme, and a phosphatase reactivates it. The kinase and the phosphatase are also regulated.

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The Biotechnology MA program trains students in modern aspects of molecular biology with a particular emphasis on approaches used in the biotechnology and pharmaceutical industries. The program provides students with an advanced scientific education and prepares them scientifically for diverse careers in the Biotechnology and Pharmaceutical industries. These careers include:

  • Research science positions in laboratories applying biotechnology to problems in medicine, industry, and agriculture
  • Careers in regulation of drug approval and other biotechnology application
  • Management positions in the biotechnology industry
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The program is intended for students who would like a career in biotechnology without making the 5-7 year commitment to attain a Ph.D. The biotechnology and pharmaceutical industries are among the largest in the U.S. and there is a great demand for professionals with biotechnology expertise.

Thirty (30) points of coursework plus a Master's thesis are required for the MA in Biotechnology. The thesis includes a review of a topic in biotechnology chosen with the help of a program advisor. An intensive laboratory course in Biotechnology is required to give students hands on experience in biotechnology methods. Elective courses (five or more) are selected according to the student’s specific interests. The program can be completed by full-time students in 1 year including the summer semester or at a reduced pace by part-time students.

Watch the video: Χαιρετισμός Βιολογική εταιρεία Κύπρου (January 2023).